Miniature Shredding Tools for Use in Medical Applications, Methods for Making, and Procedures for Using

ABSTRACT

The present disclosure relates generally to the field of tissue removal and more particularly to methods and devices for use in medical applications involving selective tissue removal. One exemplary method includes the steps of providing a tissue cutting instrument capable of distinguishing between target tissue to be removed and non-target tissue, urging the instrument against the target tissue and the non-target tissue, and allowing the instrument to cut the target tissue while automatically avoiding cutting of non-target tissue. Various tools for carrying out this method are also described.

U.S. GOVERNMENT RIGHTS

This invention was made with Government support under Grant No. R01HL087797 awarded by the National Institutes of Health. The Governmenthas certain rights in the invention.

RELATED APPLICATIONS

The below table sets forth the priority claims for the instantapplication along with filing dates, patent numbers, and issue dates asappropriate. Each of the listed applications is incorporated herein byreference as if set forth in full herein including any appendicesattached thereto.

Which was Which Filed issued on Continuity (YYYY- Which is (YYYY- DktNo. App. No. Type App. No. MM-DD) now MM-DD) Fragment This is a CIP of14/634,424 2015-02-27 pending — 265-B application 14/634,424 is a CNT of12/490,295 2009-06-23 U.S. Pat. No. 2015-03-03 265-A 8,968,34612/490,295 claims 61/075,006 2008-06-23 expired — 222-A benefit of12/490,295 claims 61/164,864 2009-03-30 expired — 222-B benefit of12/490,295 claims 61/164,883 2009-03-30 expired — 261-A benefit of Thisis a CIP of 14/452,376 2014-08-05 pending — 298-C application 14/452,376is a DIV of 13/007,578 2011-01-14 U.S. Pat. No. 2014-08-05 298-A8,795,278 13/007,578 is a CIP of 12/490,295 2009-06-23 US Pat. No.2015-03-03 265-A 8,968,346 12/490,295 claims 61/075,006 2008-06-23expired — 222-A benefit of 12/490,295 claims 61/164,864 2009-03-30expired — 222-B benefit of 12/490,295 claims 61/164,883 2009-03-30expired — 261-A benefit of 13/007,578 is a CIP of 12/490,301 2009-06-23U.S. Pat. No. 2013-07-02 266-A 8,475,458 12/490,301 claims 61/075,0062008-06-23 expired — 222-A benefit of 12/490,301 claims 61/164,8642009-03-30 expired — 222-B benefit of 12/490,301 claims 61/164,8832009-03-30 expired — 261-A benefit of 13/007,578 claims 61/408,5582010-10-29 expired — 297-A benefit of This is a CIP of 15/277,9162016-09-27 pending — 301-B application 15/277,916 is a CNT of 13/535,1972012-06-27 U.S. Pat. No. 2016-09-27 301-A 9,451,977 13/535,197 is a CIPof 13/007,578 2011-01-14 U.S. Pat. No. 2014-08-05 298-A 8,795,27813/007,578 claims 61/408,558 2010-10-29 expired — 297-A benefit of13/007,578 is a CIP of 12/490,295 2009-06-23 U.S. Pat. No. 2015-03-03265-A 8,968,346 12/490,295 claims 61/075,006 2008-06-23 expired — 222-Abenefit of 12/490,295 claims 61/164,864 2009-03-30 expired — 222-Bbenefit of 12/490,295 claims 61/164,883 2009-03-30 expired — 261-Abenefit of 13/007,578 is a CIP of 12/490,301 2009-06-23 U.S. Pat. No.2013-07-02 266-A 8,475,458 12/490,301 claims 61/075,006 2008-06-23expired — 222-A benefit of 12/490,301 claims 61/164,864 2009-03-30expired — 222-B benefit of 12/490,301 claims 61/164,883 2009-03-30expired — 261-A benefit of This is a CIP of 15/005,994 2016-01-25pending — 305-B application 15/005,994 is a DIV of 13/659,734 2012-10-24abandoned — 305-A This Is a CIP of 13/714,285 2012-12-13 pending 309-Aapplication 13/714,285 claims 61/731,434 2012-11-29 expired 307-Abenefit of This is a CIP of 13/843,462 2013-03-15 pending — 311-Aapplication 13/843,462 claims 61/731,440 2012-11-29 expired — 306-Abenefit of

FIELD OF THE INVENTION

Embodiments of the present invention relate to micro-scale andmillimeter-scale shredding devices that may, for example, be used toremove unwanted tissue or other material from selected locations withina body of a patient during a minimally invasive or other medicalprocedure, in particular embodiments multi-layer, multi-materialelectrochemical fabrication methods are used to, in whole or in part,form such devices, while in still other embodiments selected medicalprocedures are provided that use such shredding devices to achieveparticular results.

BACKGROUND OF THE INVENTION

An electrochemical fabrication technique for forming three-dimensionalstructures from a plurality of adhered layers is being commerciallypursued by Microfabrica® Inc. (formerly MEMGen Corporation) of Van Nuys,Calif. under the process names EFAB™ and MICA FREEFORM®.

Various electrochemical fabrication techniques were described in U.S.Pat. No. 6,027,630, issued on Feb. 22, 2000 to Adam Cohen. Someembodiments of this electrochemical fabrication technique allow theselective deposition of a material using a mask that includes apatterned conformable material on a support structure that isindependent of the substrate onto which plating will occur. Whendesiring to perform an electrodeposition using the mask, the conformableportion of the mask is brought into contact with a substrate, but notadhered or bonded to the substrate, while in the presence of a platingsolution such that the contact of the conformable portion of the mask tothe substrate inhibits deposition at selected locations. Forconvenience, these masks might be generically called conformable contactmasks; the masking technique may be generically called a conformablecontact mask plating process. More specifically, in the terminology ofMicrofabrica Inc. such masks have come to be known as INSTANT MASKS™ andthe process known as INSTANT MASKING™ or INSTANT MASK™ plating.Selective depositions using conformable contact mask plating may be usedto form single selective deposits of material or may be used in aprocess to form multi-layer structures. The teachings of the '630 patentare hereby incorporated herein by reference as if set forth in fullherein. Since the filing of the patent application that led to the abovenoted patent, various papers about conformable contact mask plating(i.e., INSTANT MASKING) and electrochemical fabrication have beenpublished:

-   (1) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U. Frodis and P.    Will, “EFAB: Batch production of functional, fully-dense metal parts    with micro-scale features”, Proc. 9th Solid Freeform Fabrication,    The University of Texas at Austin, p161, August 1998.-   (2) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U. Frodis and P.    Will, “EFAB: Rapid, Low-Cost Desktop Micromachining of High Aspect    Ratio True 3-D MEMS”, Proc. 12th IEEE Micro Electro Mechanical    Systems Workshop, IEEE, p244, January 1999.-   (3) A. Cohen, “3-D Micromachining by Electrochemical Fabrication”,    Micromachine Devices, March 1999.-   (4) G. Zhang, A. Cohen, U. Frodis, F. Tseng, F. Mansfeld, and P.    Will, “EFAB: Rapid Desktop Manufacturing of True 3-D    Microstructures”, Proc. 2nd International Conference on Integrated    MicroNanotechnology for Space Applications, The Aerospace Co., April    1999.-   (5) F. Tseng, U. Frodis, G. Zhang, A. Cohen, F. Mansfeld, and P.    Will, “EFAB: High Aspect Ratio, Arbitrary 3-D Metal Microstructures    using a Low-Cost Automated Batch Process”, 3rd International    Workshop on High Aspect Ratio MicroStructure Technology (HARMST'99),    June 1999.-   (6) A. Cohen, U. Frodis, F. Tseng, G. Zhang, F. Mansfeld, and P.    Will, “EFAB: Low-Cost, Automated Electrochemical Batch Fabrication    of Arbitrary 3-D Microstructures”, Micromachining and    Microfabrication Process Technology, SPIE 1999 Symposium on    Micromachining and Microfabrication, September 1999.-   (7) F. Tseng, G. Zhang, U. Frodis, A. Cohen, F. Mansfeld, and P.    Will, “EFAB: High Aspect Ratio, Arbitrary 3-D Metal Microstructures    using a Low-Cost Automated Batch Process”, MEMS Symposium, ASME 1999    International Mechanical Engineering Congress and Exposition,    November, 1999.-   (8) A. Cohen, “Electrochemical Fabrication (EFAB™)”, Chapter 19 of    The MEMS Handbook, edited by Mohamed Gad-El-Hak, CRC Press, 2002.-   (9) Microfabrication—Rapid Prototyping's Killer Application”, pages    1-5 of the Rapid Prototyping Report, CAD/CAM Publishing, Inc., June    1999.

An electrochemical deposition for forming multilayer structures may becarried out in a number of different ways as set forth in the abovepatent and publications. In one form, this process involves theexecution of three separate operations during the formation of eachlayer of the structure that is to be formed:

-   -   1. Selectively depositing at least one material by        electrodeposition upon one or more desired regions of a        substrate. Typically this material is either a structural        material or a sacrificial material.    -   2. Then, blanket depositing at least one additional material by        electrodeposition so that the additional deposit covers both the        regions that were previously selectively deposited onto, and the        regions of the substrate that did not receive any previously        applied selective depositions. Typically this material is the        other of a structural material or a sacrificial material.    -   3. Finally, planarizing the materials deposited during the first        and second operations to produce a smoothed surface of a first        layer of desired thickness having at least one region containing        the at least one material and at least one region containing at        least the one additional material.

After formation of the first layer, one or more additional layers may beformed adjacent to an immediately preceding layer and adhered to thesmoothed surface of that preceding layer. These additional layers areformed by repeating the first through third operations one or more timeswherein the formation of each subsequent layer treats the previouslyformed layers and the initial substrate as a new and thickeningsubstrate.

Once the formation of all layers has been completed, at least a portionof at least one of the materials deposited is generally removed by anetching process to expose or release the three-dimensional structurethat was intended to be formed. The removed material is a sacrificialmaterial while the material that forms part of the desired structure isa structural material.

The preferred method of performing the selective electrodepositioninvolved in the first operation is by conformable contact mask plating.In this type of plating, one or more conformable contact (CC) masks arefirst formed. The CC masks include a support structure onto which apatterned conformable dielectric material is adhered or formed. Theconformable material for each mask is shaped in accordance with aparticular cross-section of material to be plated (the pattern ofconformable material is complementary to the pattern of material to bedeposited). At least one CC mask is used for each unique cross-sectionalpattern that is to be plated.

The support for a CC mask is typically a plate-like structure formed ofa metal that is to be selectively electroplated and from which materialto be plated will be dissolved. In this typical approach, the supportwill act as an anode in an electroplating process. In an alternativeapproach, the support may instead be a porous or otherwise perforatedmaterial through which deposition material will pass during anelectroplating operation on its way from a distal anode to a depositionsurface. In either approach, it is possible for multiple CC masks toshare a common support, i.e. the patterns of conformable dielectricmaterial for plating multiple layers of material may be located indifferent areas of a single support structure. When a single supportstructure contains multiple plating patterns, the entire structure isreferred to as the CC mask while the individual plating masks may bereferred to as “submasks”. In the present application such a distinctionwill be made only when relevant to a specific point being made.

In preparation for performing the selective deposition of the firstoperation, the conformable portion of the CC mask is placed inregistration with and pressed against a selected portion of (1) thesubstrate, (2) a previously formed layer, or (3) a previously depositedportion of a layer on which deposition is to occur. The pressingtogether of the CC mask and relevant substrate occur in such a way thatall openings, in the conformable portions of the CC mask contain platingsolution. The conformable material of the CC mask that contacts thesubstrate acts as a barrier to electrodeposition while the openings inthe CC mask that are filled with electroplating solution act as pathwaysfor transferring material from an anode (e.g. the CC mask support) tothe non-contacted portions of the substrate (which act as a cathodeduring the plating operation) when an appropriate potential and/orcurrent are supplied.

An example of a CC mask and CC mask plating are shown in FIGS. 1A-1C.FIG. 1A shows a side view of a CC mask 8 consisting of a conformable ordeformable (e.g. elastomeric) insulator 10 patterned on an anode 12. Theanode has two functions. One is as a supporting material for thepatterned insulator 10 to maintain its integrity and alignment since thepattern may be topologically complex (e.g., involving isolated “islands”of insulator material). The other function is as an anode for theelectroplating operation. FIG. 1A also depicts a substrate 6, separatedfrom mask 8, onto which material will be deposited during the process offorming a layer. CC mask plating selectively deposits material 22 ontosubstrate 6 by simply pressing the insulator against the substrate thenelectrodepositing material through apertures 26 a and 26 b in theinsulator as shown in FIG. 1B. After deposition, the CC mask isseparated, preferably non-destructively, from the substrate 6 as shownin FIG. 10.

The CC mask plating process is distinct from a “through-mask” platingprocess in that in a through-mask plating process the separation of themasking material from the substrate would occur destructively.Furthermore in a through mask plating process, opening in the maskingmaterial are typically formed while the masking material is in contactwith and adhered to the substrate. As with through-mask plating, CC maskplating deposits material selectively and simultaneously over the entirelayer. The plated region may consist of one or more isolated platingregions where these isolated plating regions may belong to a singlestructure that is being formed or may belong to multiple structures thatare being formed simultaneously. In CC mask plating as individual masksare not intentionally destroyed in the removal process, they may beusable in multiple plating operations.

Another example of a CC mask and CC mask plating is shown in FIGS.1D-1G. FIG. 1D shows an anode 12′ separated from a mask 8′ that includesa patterned conformable material 10′ and a support structure 20. FIG. 1Dalso depicts substrate 6 separated from the mask 8′. FIG. 1E illustratesthe mask 8′ being brought into contact with the substrate 6. FIG. 1Fillustrates the deposit 22′ that results from conducting a current fromthe anode 12′ to the substrate 6. FIG. 1G illustrates the deposit 22′ onsubstrate 6 after separation from mask 8′. In this example, anappropriate electrolyte is located between the substrate 6 and the anode12′ and a current of ions coming from one or both of the solution andthe anode are conducted through the opening in the mask to the substratewhere material is deposited. This type of mask may be referred to as ananodeless INSTANT MASK™ (AIM) or as an anodeless conformable contact(ACC) mask.

Unlike through-mask plating, CC mask plating allows CC masks to beformed completely separate from the substrate on which plating is tooccur (e.g. separate from a three-dimensional (3D) structure that isbeing formed). CC masks may be formed in a variety of ways, for example,using a photolithographic process. All masks can be generatedsimultaneously, e.g. prior to structure fabrication rather than duringit. This separation makes possible a simple, low-cost, automated,self-contained, and internally-clean “desktop factory” that can beinstalled almost anywhere to fabricate 3D structures, leaving anyrequired clean room processes, such as photolithography to be performedby service bureaus or the like.

An example of the electrochemical fabrication process discussed above isillustrated in FIGS. 2A-2F. These figures show that the process involvesdeposition of a first material 2 which is a sacrificial material and asecond material 4 which is a structural material. The CC mask 8, in thisexample, includes a patterned conformable material (e.g. an elastomericdielectric material) 10 and a support 12 which is made from depositionmaterial 2. The conformal portion of the CC mask is pressed againstsubstrate 6 with a plating solution 14 located within the openings 16 inthe conformable material 10. An electric current, from power supply 18,is then passed through the plating solution 14 via (a) support 12 whichdoubles as an anode and (b) substrate 6 which doubles as a cathode. FIG.2A illustrates that the passing of current causes material 2 within theplating solution and material 2 from the anode 12 to be selectivelytransferred to and plated on the substrate 6. After electroplating thefirst deposition material 2 onto the substrate 6 using CC mask 8, the CCmask 8 is removed as shown in FIG. 2B. FIG. 2C depicts the seconddeposition material 4 as having been blanket-deposited (i.e.non-selectively deposited) over the previously deposited firstdeposition material 2 as well as over the other portions of thesubstrate 6. The blanket deposition occurs by electroplating from ananode (not shown), composed of the second material, through anappropriate plating solution (not shown), and to the cathode/substrate6. The entire two-material layer is then planarized to achieve precisethickness and flatness as shown in FIG. 2D. After repetition of thisprocess for all layers, the multi-layer structure 20 formed of thesecond material 4 (i.e. structural material) is embedded in firstmaterial 2 (i.e. sacrificial material) as shown in FIG. 2E. The embeddedstructure is etched to yield the desired device, i.e. structure 20, asshown in FIG. 2F.

Various components of an exemplary manual electrochemical fabricationsystem 32 are shown in FIGS. 3A-3C. The system 32 consists of severalsubsystems 34, 36, 38, and 40. The substrate holding subsystem 34 isdepicted in the upper portions of each of FIGS. 3A-3C and includesseveral components: (1) a carrier 48, (2) a metal substrate 6 onto whichthe layers are deposited, and (3) a linear slide 42 capable of movingthe substrate 6 up and down relative to the carrier 48 in response todrive force from actuator 44. Subsystem 34 also includes an indicator 46for measuring differences in vertical position of the substrate whichmay be used in setting or determining layer thicknesses and/ordeposition thicknesses. The subsystem 34 further includes feet 68 forcarrier 48 which can be precisely mounted on subsystem 36.

The CC mask subsystem 36 shown in the lower portion of FIG. 3A includesseveral components: (1) a CC mask 8 that is actually made up of a numberof CC masks (i.e. submasks) that share a common support/anode 12, (2)precision X-stage 54, (3) precision Y-stage 56, (4) frame 72 on whichthe feet 68 of subsystem 34 can mount, and (5) a tank 58 for containingthe electrolyte 16. Subsystems 34 and 36 also include appropriateelectrical connections (not shown) for connecting to an appropriatepower source (not shown) for driving the CC masking process.

The blanket deposition subsystem 38 is shown in the lower portion ofFIG. 3B and includes several components: (1) an anode 62, (2) anelectrolyte tank 64 for holding plating solution 66, and (3) frame 74 onwhich feet 68 of subsystem 34 may sit. Subsystem 38 also includesappropriate electrical connections (not shown) for connecting the anodeto an appropriate power supply (not shown) for driving the blanketdeposition process.

The planarization subsystem 40 is shown in the lower portion of FIG. 3Cand includes a lapping plate 52 and associated motion and controlsystems (not shown) for planarizing the depositions.

In addition to teaching the use of CC masks for electrodepositionpurposes, the '630 patent also teaches that the CC masks may be placedagainst a substrate with the polarity of the voltage reversed andmaterial may thereby be selectively removed from the substrate. Itindicates that such removal processes can be used to selectively etch,engrave, and polish a substrate, e.g., a plaque.

The '630 patent further indicates that the electroplating methods andarticles disclosed therein allow fabrication of devices from thin layersof materials such as, e.g., metals, polymers, ceramics, andsemiconductor materials. It further indicates that although theelectroplating embodiments described therein have been described withrespect to the use of two metals, a variety of materials, e.g.,polymers, ceramics and semiconductor materials, and any number of metalscan be deposited either by the electroplating methods therein, or inseparate processes that occur throughout the electroplating method. Itindicates that a thin plating base can be deposited, e.g., bysputtering, over a deposit that is insufficiently conductive (e.g., aninsulating layer) so as to enable subsequent electroplating. It alsoindicates that multiple support materials (i.e. sacrificial materials)can be included in the electroplated element allowing selective removalof the support materials.

The '630 patent additionally teaches that the electroplating methodsdisclosed therein can be used to manufacture elements having complexmicrostructure and close tolerances between parts. An example is givenwith the aid of FIGS. 14A-14E of that patent. In the example, elementshaving parts that fit with close tolerances, e.g., having gaps betweenabout 1-5 um, including electroplating the parts of the device in anunassembled, preferably pre-aligned, state and once fabricated. In suchembodiments, the individual parts can be moved into operational relationwith each other or they can simply fall together. Once together theseparate parts may be retained by clips or the like.

Another method for forming microstructures from electroplated metals(i.e. using electrochemical fabrication techniques) is taught in U.S.Pat. No. 5,190,637 to Henry Guckel, entitled “Formation ofMicrostructures by Multiple Level Deep X-ray Lithography withSacrificial Metal layers”. This patent teaches the formation of metalstructure utilizing through mask exposures. A first layer of a primarymetal is electroplated onto an exposed plating base to fill a void in aphotoresist (the photoresist forming a through mask having a desiredpattern of openings), the photoresist is then removed and a secondarymetal is electroplated over the first layer and over the plating base.The exposed surface of the secondary metal is then machined down to aheight which exposes the first metal to produce a flat uniform surfaceextending across both the primary and secondary metals. Formation of asecond layer may then begin by applying a photoresist over the firstlayer and patterning it (i.e. to form a second through mask) and thenrepeating the process that was used to produce the first layer toproduce a second layer of desired configuration. The process is repeateduntil the entire structure is formed and the secondary metal is removedby etching. The photoresist is formed over the plating base or previouslayer by casting and patterning of the photoresist (i.e. voids formed inthe photoresist) are formed by exposure of the photoresist through apatterned mask via X-rays or UV radiation and development of the exposedor unexposed areas.

The '637 patent teaches the locating of a plating base onto a substratein preparation for electroplating materials onto the substrate. Theplating base is indicated as typically involving the use of a sputteredfilm of an adhesive metal, such as chromium or titanium, and then asputtered film of the metal that is to be plated. It is also taught thatthe plating base may be applied over an initial layer of sacrificialmaterial (i.e. a layer or coating of a single material) on the substrateso that the structure and substrate may be detached if desired. In suchcases after formation of the structure the sacrificial material formingpart of each layer of the structure may be removed along the initialsacrificial layer to free the structure. Substrate materials mentionedin the '637 patent include silicon, glass, metals, and silicon withprotected semiconductor devices. A specific example of a plating baseincludes about 150 angstroms of titanium and about 300 angstroms ofnickel, both of which are sputtered at a temperature of 160° C. Inanother example it is indicated that the plating base may consist of 150angstroms of titanium and 150 angstroms of nickel where both are appliedby sputtering.

Electrochemical Fabrication provides the ability to form prototypes andcommercial quantities of miniature objects, parts, structures, devices,and the like at reasonable costs and in reasonable times. In fact,Electrochemical Fabrication is an enabler for the formation of manystructures that were hitherto impossible to produce. ElectrochemicalFabrication opens the spectrum for new designs and products in manyindustrial fields. Even though Electrochemical Fabrication offers thisnew capability and it is understood that Electrochemical Fabricationtechniques can be combined with designs and structures known withinvarious fields to produce new structures, certain uses forElectrochemical Fabrication provide designs, structures, capabilitiesand/or features not known or obvious in view of the state of the art.

A need exists in various fields for miniature devices having improvedcharacteristics, reduced fabrication times, reduced fabrication costs,simplified fabrication processes, greater versatility in device design,improved selection of materials, improved material properties, more costeffective and less risky production of such devices, and/or moreindependence between geometric configuration and the selectedfabrication process.

The medical device field is one area which can benefit from the abilityto produce a device (e.g., implantable devices, tools used in medicalprocedures, including surgical procedures and minimally invasiveprocedures, etc.), or certain parts of the device, with very smalldimensions, or from the ability to produce devices or parts of thedevice with small dimensions, but with improved performance overexisting products and procedures. Some medical procedures include, orconsist primarily of, the removal of tissue from a subject. The tissuecan be native to the subject or tissue which may be considered to beforeign tissue (e.g. tumor mass).

Some devices with relatively large dimensions risk removing unintendedtissue from the subject, or damaging the unintended tissue. There is aneed for tissue removal devices which have small dimensions and improvedfunctionality which allow them to more safely remove only the desiredtissue from the patient. There is also a need for tissue removal deviceswhich have small dimensions and improved functionality over existingproducts and procedures which allow them to more efficiently removetissue from the patient.

One portion of the body in which tissue can be removed to treat avariety of conditions is the spine area. Tissue removal devices for thespine are needed that can produced with sufficiently small dimensionand/or that have increased performance over existing techniques. Forexample, a herniated disc or bulging disc can be treated by performing adiscectomy, e.g. by removing all or part of the nucleus pulposus of thedamaged disc. Such procedures may also involve a laminotomy orlaminectomy wherein a portion or all of a lamina may be removed to allowaccess to the herniated disc. Artificial disc replacement (total orpartial) is another example of a procedure which requires the removal ofall or a portion of the disc, which is replaced with an artificialdevice or material.

Prior art tissue removal devices often remove tissue in large pieces,having dimensions well over 2 mm. The tissue pieces are removed throughan aspiration lumen typically 3.5 to 5 mm in diameter. Since the tissuepieces being removed commonly have dimensions that are 1 to 2 lumendiameters in length, the tissue pieces can often clog the tissue removallumen.

Tissue removal devices are needed which can be produced with sufficientmechanical complexity and a small size so that they can both safely andmore efficiently remove tissue from a subject, and/or remove tissue in aless invasive procedure and/or with less damage to adjacent tissue suchthat risks are lowered and recovery time is improved. Additionally,tissue removal devices are needed which can aid a surgeon byautomatically selecting between target tissue to be removed andnon-target tissue that is to be left intact.

SUMMARY OF THE INVENTION

This application and its parent applications are directed to, intraalia, miniature devices for shredding or debriding tissue, systems thatinclude such devices, methods for making such devices and/or systems,and medical procedures that use such devices or systems to provide abenefit to a patient (e.g. as part of a minimally invasive surgicalprocedure). As noted above, teachings set forth in the parentapplications are incorporated herein by reference and form an integralpart of the teachings hereof.

According to some embodiments of the disclosure, methods of selectivelyremoving tissue are provided. One exemplary method includes the steps ofproviding a tissue cutting instrument capable of distinguishing betweentarget tissue to be removed and non-target tissue, urging the instrumentagainst the target tissue and the non-target tissue, and allowing theinstrument to cut the target tissue while automatically avoiding cuttingof non-target tissue.

According to some embodiments of the disclosure, debridement instrumentsare provided. One exemplary instrument includes an elongated introducerhaving a proximal end and a distal end, and a cutter housing locatednear the distal end of the introducer. In this embodiment, at least onecutter element is rotably mounted to the cutter housing. The cutterelement is configured to remove portions of soft tissue from a body. Theinstrument also includes a tissue removal lumen extending along theintroducer and having an inlet within the cutter housing. The lumen isconfigured to remove the tissue portions cut by the cutter element. Theinstrument is configured to ensure that the portions of removed tissuehave a maximum dimension less than about 2 mm across before they passthrough the tissue removal lumen inlet. In some embodiments havinglarger instruments, the maximum tissue dimension is larger than about 2mm.

According to some embodiments of the disclosure, a method of selectivelyremoving soft target tissue from a body includes providing an instrumentcomprising an elongated introducer, a cutter housing located near adistal end of the introducer, and at least one cutter element rotablymounted to the cutter housing. The cutter element is rotated, and thecutter element and soft target tissue are caused to come into contactwith one another such that the rotating cutter element cuts off portionsof the soft target tissue. The instrument is configured to cut thetissue in portions having a maximum dimension less than 2 mm across. Thecut tissue portions are removed through a tissue removal lumen extendingfrom adjacent the cutter element and along the introducer.

The disclosure of the present invention provides a number of deviceembodiments which may be fabricated, but are not necessarily fabricated,from a plurality of formed and adhered layers with each successive layerincluding at least two materials, one of which is a structural materialand the other of which is a sacrificial material, and wherein eachsuccessive layer defines a successive cross-section of thethree-dimensional structure, and wherein the forming of each of theplurality of successive layers includes: (i) depositing a first of theat least two materials; (ii) depositing a second of the at least twomaterials; and (B) after the forming of the plurality of successivelayers, separating at least a portion of the sacrificial material fromthe structural material to reveal the three-dimensional structure. Insome embodiments, the device may include a plurality of componentsmovable relative to one another which contain etching holes which may bealigned during fabrication and during release from at least a portion ofthe sacrificial material.

The Ser. No. 14/634,424 Application:

This referenced application includes, inter alia, teachings directed tothe use of multi-layer multi-material electrochemical fabricationmethods for producing shredding devices and more particularly to tissueshredding devices for use in medical applications. Some such medicalapplications include treatment of herniated discs and thrombectomyprocedures. The present invention relates generally to the field ofmicro-scale or millimeter scale devices and to the use of multi-layermulti-material electrochemical fabrication methods for producing suchdevices with particular embodiments relate to shredding devices and moreparticularly to shredding devices for use in medical applications. Insome embodiments, tissue removal devices are used in procedures toremoval spinal tissue and in other embodiments, similar devices are usedto remove thrombus from blood vessel.

The Ser. No. 14/452,376 Application:

This referenced application includes, inter alia, teachings directed tothe field of tissue removal and more particularly to methods and devicesfor use in medical applications involving selective tissue removal. Oneexemplary method includes the steps of providing a tissue cuttinginstrument capable of distinguishing between target tissue to be removedand non-target tissue, urging the instrument against the target tissueand the non-target tissue, and allowing the instrument to cut the targettissue while automatically avoiding cutting of non-target tissue.Various tools for carrying out this method are also described.

This referenced application includes, inter alia, teachings directed toMedical devices for shearing tissue into small pieces. One exemplarydevice includes oppositely rotating first and second rotatable members,each located at least partially within a distal housing. The device alsoincludes first and second circular axle portions, and first and secondblades that are directly adjacent to one another and positioned topartially overlap such that tissue may be sheared between the first andsecond blades, between the first blade and the second axle portion andbetween the second blade and the first axle portion. The rotatablemembers are configured to engage tissue from a target tissue site withteeth of the first and second blades rotating towards one another andinwardly to direct tissue from the target tissue site through a tissueengaging opening and into an interior portion of the distal housing.Methods of fabricating and using the above device are also disclosed.

The Ser. No. 15/005,994 Application:

This referenced application includes, inter alia, teachings directed toa medical device for removing tissue from a subject is provided with adistal housing, an elongate member, a first rotatable member and firstand second tissue shearing surfaces. The distal housing is configuredwith at least one tissue engaging opening. The elongate member iscoupled to the distal housing and configured to introduce the distalhousing to a target tissue site. The first rotatable member is locatedat least partially within the distal housing. The first and secondtissue shearing surfaces are located and configured to cooperate withfirst and second sides of a first blade to shear tissue therebetween.The first rotatable member is configured to engage tissue from thetarget tissue site, rotate towards the first and second tissue shearingsurfaces and inwardly to direct tissue from the target tissue sitethrough the tissue engaging opening and into an interior portion of thedistal housing.

The Ser. No. 13/714,285 Application:

This referenced application includes, inter alia, teachings directed toa bendable medical device such as one for removing tissue from asubject. The device includes a distal housing, an outer support tube, aninner drive tube, a coupler and a commutator portion. The coupler andcommutator portion serve to axially constrain a distal end of the innerdrive tube during bending, and to supply fluid for lubricating, coolingand irrigating the distal end of the device.

The Ser. No. 13/843,462 Application:

This referenced application includes, inter alia, teachings directed toa medical device for removing tissue from a subject is provided with adistal housing configured with a tissue cutter assembly, an elongatemember coupled to the distal housing and having an outer tube and aninner drive tube with a crown gear located on a distal end thereof,first and second rotatable members each rotatably mounted to the tissuecutter assembly, a first drive gear train coupled between the crown gearand the first rotatable member, and a second drive gear train coupledbetween the crown gear and the second rotatable member. The first andsecond drive gear trains are configured to drive the first and secondrotatable members, respectively, in opposite directions. Concave andconvex gear tooth profiles are also disclosed for improved performanceof the first and second drive gear trains.

Aspects of the Invention

Each of the aspects of the invention that follow or are otherwiseascertained from the present disclosure, represent different andpotentially independently claimable inventions while each variation ofan aspect represents an additional potentially independently claimableinvention.

A first aspect of the invention provides a microscale or millimeterscale shredding tool, including: (a) a housing having a distal end and aproximal end; (b) a first multi-blade blade stack mounted for rotationalmotion about a first axis relative to the housing and extending in partfrom the housing; (c) a second multi-blade blade stack mounted forrotational motion, about a second axis which is parallel to the firstaxis, relative to the housing and extending in part from the housing,wherein a least a portion of the blades of the second blade stack haveinterlaced positions with blades of the first stack in a planeperpendicular to the first and second axes of rotation but which areoffset in the direction of the first and second axis so that the bladesof first stack do not interfere with the blades of the second stack; and(d) a drive mechanism for rotating the blades of the first stack and theblades of the second stack in opposite directions; wherein one or moreof the following elements are also provided: (i) the drive mechanismincludes a first gear train for driving the first blade stack and asecond gear train for driving the second blade stack wherein the firstgear train interacts with the first blade stack from above while thesecond gear train interacts with the second blade stack from below; (ii)at least a plurality of components of the device are formed in desiredrelative positions using a multi-material, multilayer electrochemicalfabrication process; (iii) a plurality of multitier gears, include: (1)a first multi-tiered gear having a lower gear element and an upper gearelement wherein the angular spacing between teeth on the upper gearelement is a multiple of a desired interaction spacing, wherein theangular spacing between teeth on the lower gear element is a multiple ofthe desired interaction spacing, and wherein the teeth of the lower gearelement are rotated relative to the teeth of the upper gear element,such that the multiple tiers of the first multi-tier gear taken as wholedefine a gear assembly having the desired interaction spacing but withoffset levels; and (2) a second multi-tiered gear having a lower gearelement and an upper gear element wherein the angular spacing betweenteeth on the upper gear element is a multiple of a desired interactionspacing, wherein the angular spacing between teeth on the lower gearelement is a multiple of the desired interaction spacing, and whereinthe teeth of the lower gear element are rotated relative to the teeth ofthe upper gear element, such that the multiple tiers of the secondmulti-tier gear taken as whole define a gear assembly having the desiredinteraction spacing but with offset levels; wherein the lower levelteeth of the first and second multi-tier gear elements interact and theupper teeth of the first and second multi-tier gear element interactduring rotation such that the first and second multi-tier gears functionas if they were single tier gears having the desired angular spacing andwherein the interaction precision is higher than that allowed by aminimum feature size existing for the process used in forming the firstand second multi-tier gear elements while in fully assembled positions;(iv) the drive mechanism includes at least one gear train that isisolated from material shredded by the blades by a shield; (v) the drivemechanism includes a coupler in which a rotating drive shaft can beinserted; (vi) the drive mechanism includes a pulley and a belt; (vii)the drive mechanism includes a sprocket and chain; (viii) the drivemechanism includes a pneumatic turbine; and/or (ix) the drive mechanismincludes a hydraulic turbine.

Numerous variations of this first aspect of the invention are possibleand include, for example: (1) the blades are configured to draw materialinto the housing upon shredding; (2) the first and second blade stacksextend from the distal end of the housing; (3) the first and secondblade stacks extend from a side of the housing; (4) third and fourthblade stacks that extend from an opposite sides of the housing relativeto the side of the housing from which the first and second blade stacksextend; (5) the first and second blade stacks are retractable into andextendible, at least in part from the housing; (6) the housing includesone or more filter elements that allow only material below a certainsize to leave the housing; (7) the device being put to use in aminimally invasive medical procedure; (8) the device being coupled to adelivery device; and/or (9) the device is being formed at least in partusing a multi-layer material electrochemical fabrication method whereinat least two components of the device that are moveable relative to eachother during normal operation and are possibly formed with etching holesthat are aligned during the fabrication process.

The second aspect of the invention provides a microscale or millimeterscale device for performing a desired function, including: (a) ahousing; (b) a first moving component supported directly or indirectlyby the housing; and (c) a second moving component supported directly orindirectly by the housing; wherein the first and second movingcomponents interact via a plurality of multitier gears.

Numerous variations of the second aspect of the invention are possibleand include, for example: (1) the plurality of multi-tier gears,include: (a) a first multi-tiered gear having a lower gear element andan upper gear element wherein the angular spacing between teeth on theupper gear element is a multiple of a desired interaction spacing,wherein the angular spacing between teeth on the lower gear element is amultiple of the desired interaction spacing, and wherein the teeth ofthe lower gear element are rotated relative to the teeth of the uppergear element, such that the multiple tiers of the first multi-tier geartaken as whole define a gear assembly having the desired interactionspacing but with offset levels; and (b) a second multi-tiered gearhaving a lower gear element and an upper gear element wherein theangular spacing between teeth on the upper gear element is a multiple ofa desired interaction spacing, wherein the angular spacing between teethon the lower gear element is a multiple of the desired interactionspacing, and wherein the teeth of the lower gear element are rotatedrelative to the teeth of the upper gear element, such that the multipletiers of the second multi-tier gear taken as whole define a gearassembly having the desired interaction spacing but with offset levels;and wherein the lower level teeth of the first and second multi-tiergear elements interact and the upper teeth of the first and secondmulti-tier gear element interact during rotation such that the first andsecond multi-tier gears function as if they were single tier gearshaving the desired angular spacing and wherein the interaction toleranceis higher than that allowed by a minimum feature size existing for theprocessed used in forming the first and second multi-tier gear elementswhile in fully assembled positions.

The third aspect of the invention provides a minimally invasive medicalprocedure for providing a medically useful procedure to a body of apatient, including: (a) inserting a lumen, having a distal and proximalend into the body of a patient such that the proximal end remainsoutside the body of the patient while the distal end is located inproximity to a desired location; (b) inserting a device into the lumento and moving the device to the desired location; (c) operating thedevice at the desired location wherein the device includes a tissueshredding device of any of the first or second aspects or any of theirvariations.

A fourth aspect of the invention provides a method for fabricating adevice, including: (a) forming a plurality of adhered layers ofmaterial, wherein the forming of each layer of material includes: (i)deposition of at least a first material; (ii) deposition of at least asecond material; and (iii) planarization of the first and secondmaterials to a common level; and (b) removing of at least a portion ofthe first or second material after formation of the plurality of layers;wherein the device includes tissue shredding device of any of first orsecond aspect of the invention or any of their variations.

A fifth aspect of the invention provides a medical device for removingtissue from a subject, including: (a) a distal housing including aplurality of rotatable members configured to rotate and direct tissueinto an interior portion of the distal housing; (b) an elongate membercoupled to the distal housing for introducing the distal housing to atarget tissue site.

A sixth aspect of the invention provides a medical device for removingtissue from a subject, including: (a) a distal housing including at twogroups of planar rotatable members oriented in an XY plane which arespaced from one another along a Z-axis which is perpendicular to the XYplane and wherein a plurality of rotatable members in each of the twogroups at least in part occupy similar XY space during rotation and arespaced along the Z-axis from members in the opposite group by an amountin the range of 2 and 100 microns, more preferably in a range of between2 and 20 microns, and even more preferably in a range of between 2 and 8microns.

A seventh aspect of the invention provides a medical assembly forremoving tissue from a patient, including: (a) a distal housing withfirst and second oppositely rotating tissue processing members; (b) anelongate introducer coupled to the distal housing for advancing thedistal housing adjacent target tissue; (c) a delivery member with alumen adapted to receive the distal housing and elongate introducer; and(d) an actuation member adapted to control the operation of the firstand second oppositely rotating tissue processing members.

An eighth aspect of the invention provides a gear train, including: (a)a first gear with a first tooth and a second tooth; and (b) a secondgear with a third tooth and a fourth tooth; wherein the first tooth isin a first plane orthogonal to the axis of rotation of the first gear,and wherein the second tooth is in second plane orthogonal to the axisof rotation of the first gear, and wherein the planes do not overlapalong a height dimension of the first gear.

A ninth aspect of the invention provides a debridement instrument,including: (a) an elongated introducer having a proximal end and adistal end; (b) a cutter housing located near the distal end of theintroducer; (c) at least one cutter element rotatably mounted to thecutter housing, the cutter element being configured to remove portionsof soft tissue from a body; and (e) a tissue removal lumen extendingalong the introducer and having an inlet within the cutter housing,wherein the lumen is configured to remove the tissue portions cut by thecutter element, wherein the instrument is configured to ensure that theportions of removed tissue have a maximum dimension less than about 2 mmacross before they pass through the tissue removal lumen inlet.

Numerous variations of the ninth aspect of the invention are possibleand include, for example: (1) the at least one cutter element beingconfigured to remove soft tissue from the body in portions having amaximum dimension less than about 2 mm across; (2) the at least onecutter element being configured to remove soft tissue from the body inportions having a maximum dimension greater than a maximumcross-sectional dimension of the cutter housing, and wherein theinstrument is configured to morcellate the removed tissue portions suchthat they have a maximum dimension less than about 2 mm across beforethey pass through the tissue removal lumen inlet; (3) the at least onecutter element being configured to remove soft tissue from the body inportions having a maximum dimension greater than or equal to about 2 mmacross, and wherein the instrument is configured to morcellate theremoved tissue portions such that they have a maximum dimension lessthan about 2 mm across before they pass through the tissue removal lumeninlet; (4) variation (3) wherein the at least one cutter element isconfigured to both remove and morcellate the soft tissue; (5) variation(4) wherein the at least one cutter element is configured to interactwith the cutter housing to morcellate the soft tissue; (6) variation (4)further including at least two tissue cutter elements, each ratablymounted to the cutter housing, wherein the at least two cutter elementsare configured to interact with each other to morcellate the softtissue; (7) variation (3) wherein the at least one cutter element isconfigured to remove a patch of tissue that is wider than a maximumdiameter of the cutter housing, and wherein the instrument is configuredto morcellate the removed patch of tissue into portions having a maximumdimension less than about 2 mm across before the portions pass throughthe tissue removal lumen inlet; (8) an irrigation lumen distinct fromthe tissue removal lumen and extending along the introducer, theirrigation lumen having an outlet adjacent to the at least one cutterelement; (9) the elongated introducer having a longitudinal axisextending between the proximal end and the distal end of the introducer,wherein the at least one cutter element has an axis of rotation that isnon-parallel to the longitudinal axis of the introducer; (10) themaximum dimension of the tissue portions being at least one order ofmagnitude less than a diameter of the tissue removal lumen; (11) themaximum dimension of the tissue portions being at least twenty timesless than a diameter of the tissue removal lumen; (12) the maximumdimension of the tissue portions being less than about 1000 microns;(13) the maximum dimension of the tissue portions being less than about500 microns; (14) the maximum dimension of the tissue portions beingless than about 100 microns; (15) the maximum dimension of the tissueportions being about 2 microns; (16) only a portion of the cutterelement protruding from the housing; (17) variation (16) wherein thecutter element protrudes from the housing less than about 1000 microns;(18) variation (16) wherein the cutter element protrudes from thehousing less than about 500 microns; (19) variation (16) wherein thecutter element protrudes from the housing less than about 100 microns;and (20) variation (16) wherein the cutter element protrudes from thehousing less than about 10 microns.

Additional variations of the ninth aspect of the invention are possibleand include, for example: (21) the entire cutter element being coveredby the housing and a portion of an outer circumference of the cuttingelement being substantially flush with a tissue access opening in thehousing; (22) the entire cutter element being covered by the housing andan outer circumference of the cutting element being recessed within atissue access opening in the housing a minimum of about 10 microns; (23)the at least one cutter element including at least one rotatably mountedblade, the blade including at least one radially protruding tooth; (24)variation (23) wherein the at least one cutter element further includesat least one radially recessed trough associated with the tooth; (25)variation (24) wherein the blade trough has a nominal diameter of lessthan about 100 microns; (26) variation (24) wherein the blade trough hasa nominal diameter of less than about 10 microns; (27) variation (23)wherein the at least one tooth is configured with a negative angle ofattack; (28) variation (23) wherein the at least one tooth is configuredwith a positive or neutral angle of attack and does not protrude fromthe housing; (29) variation (23) wherein the at least one tooth of theat least one blade is configured to cut in both a clockwise and acounter-clockwise rotation direction of the blade; (30) the instrumentbeing configured to alternately rotate the at least one blade againsttarget tissue in a first cutting state and a second non-cutting state,the instrument being further configured to allow a user to move betweenthe first and the second states during use; (31) variation (30) whereinmovement between the first and the second states includes changing anamount of suction associated with the tissue removal lumen inlet; (32)variation (30) wherein movement between the first and the second statesincludes changing the rotation speed of the at least one blade; (33)variation (30) wherein movement between the first and the second statesincludes changing a rate of aspiration; (34) the cutter housingincluding two adjacent cutter elements rotatable in opposite directions,each cutter element including at least one blade, the blade or blades ofone cutter element being parallel to, axially offset from, and radiallyoverlapping with the blade or blades of the other cutter element, anaxial clearance between the blades of opposing cutter elements beingless than one fifth of a thickness of the blades; (35) the cutterhousing including two adjacent cutter elements rotatable in oppositedirections, each cutter element including at least one blade, the bladeor blades of one cutter element being parallel to, axially offset from,and radially overlapping with the blade or blades of the other cutterelement, an axial clearance between the blades of opposing cutterelements being less than about 10 microns; (36) the cutter housingincluding two adjacent cutter elements rotatable in opposite directions,each cutter element including at least one blade, the blade or blades ofone cutter element being parallel to, axially offset from, and radiallyoverlapping with the blade or blades of the other cutter element, anaxial clearance between the blades of opposing cutter elements beingabout 5 microns; (37) variation (34) wherein the at least one blade ofeach cutter element includes at least one tooth; (38) variation (34)wherein the instrument is configured to rotate one of the cutterelements at a speed different than the speed of the other cutterelement; (39) variation (34) wherein each of the cutter elementsincludes a stack of axially aligned blades mounted on an axle, thedistance between a maximum diameter of the blades of one cutter elementand the axle of the other cutter element being less than a thickness ofthe blades; and (40) variation (34) wherein each of the cutter elementsincludes a stack of axially aligned blades, wherein a blade of at leastone of the cutter elements has teeth that are rotationally out of phasewith the teeth of another blade in that cutter element.

Additional variations of the ninth aspect of the invention are possibleand include, for example: (41) variation (34) wherein each of the cutterelements is configured to pretension fibers of the soft target tissuebefore pulling the fibers between the cutting elements and shearing themfrom the target tissue, thereby allowing precise removal of a swath ofsoft tissue that is at least as wide as the cutter housing; (42)variation (34) wherein the two cutter elements are configured tomechanically remove a swath of tissue that is wider than a maximum widthof the cutter housing; (43) variation (34) wherein the axial clearancebetween the blades of opposing cutter elements is less than about 20microns; (44) variation (34) wherein the axial clearance between theblades of opposing cutter elements is less than about 10 microns; (45)variation (34) wherein the axial clearance between the blades ofopposing cutter elements is less than about 5 microns; (46) variation(34) wherein the axial clearance between the blades of opposing cutterelements is less than about 1 micron; (47) variation (34) wherein thereis substantially zero axial clearance between the blades of opposingcutter elements; (48) variation (34) wherein the instrument had aninitial interference fit of at least about 2 microns in the axialdirection between the blades of opposing cutter elements before abreak-in period; (49) variation (34) wherein the instrument had aninitial interference fit of at least about 5 microns in the axialdirection between the blades of opposing cutter elements before abreak-in period; (50) variation (39) wherein the distance between themaximum diameter of the blades of one cutter element and the axle of theother cutter element is less than about 10 microns; (51) variation (39)wherein the distance between the maximum diameter of the blades of onecutter element and the axle of the other cutter element is less thanabout 5 microns; (52) variation (39) wherein the distance between themaximum diameter of the blades of one cutter element and the axle of theother cutter element is less than about 1 micron; (53) variation (39)wherein the distance between the maximum diameter of the blades of onecutter element and the axle of the other cutter element is about 0microns; (54) variation (39) wherein the instrument had an initialinterference fit of at least about 2 microns between the maximumdiameter of the blades of one cutter element and the axle of the othercutter element before a break-in period; (55) variation (39) wherein theinstrument had an initial interference fit of at least about 5 micronsbetween the maximum diameter of the blades of one cutter element and theaxle of the other cutter element before a break-in period; (56) adistance between a maximum diameter of the at least one cutter elementand an adjacent portion of the cutter housing being less than about 10microns; (57) a distance between a maximum diameter of the at least onecutter element and an adjacent portion of the cutter housing being lessthan about 5 microns; (58) a distance between a maximum diameter of theat least one cutter element and an adjacent portion of the cutterhousing being less than about 1 micron; (59) a distance between amaximum diameter of the at least one cutter element and an adjacentportion of the cutter housing being about 0 microns; and (60) theinstrument having an initial interference fit of at least 2 micronsbetween a maximum diameter of the at least one cutter element and anadjacent portion of the cutter housing before a break-in period.

Additional variations of the ninth aspect of the invention are possibleand include, for example: (61) the instrument having an initialinterference fit of at least 5 microns between a maximum diameter of theat least one cutter element and an adjacent portion of the cutterhousing before a break-in period; (62) the instrument being configuredto electronically sense a transition between two different tissue types;(63) variation (62) wherein the instrument is configured with a circuitthat can monitor changes in current being delivered to a motor thatdrives the at least one cutter element; (64) variation (62) wherein theinstrument is configured with a circuit that can monitor changes orinterruptions in a velocity of the at least one cutter element or adrive system driving the at least one cutter element; (65) variation(62) wherein the instrument includes a sensing element capable ofsensing at least one parameter selected from the group consisting of:capacitance, inductance, optical changes, pressure, proximity andposition; (66) variation (62) wherein the instrument includes a sensingelement capable of sensing a pressure transition between a tissueenvironment and a fluid environment; (67) variation (66) wherein thesensing element is capable of sensing a pressure transition from afibrous tissue to an open cavity; and (68) variation (66) wherein thesensing element is capable of sensing a pressure transition from an opencavity to a fibrous tissue.

A tenth aspect of the invention provides a method of selectivelyremoving soft target tissue from a body, including: (a) providing aninstrument including an elongated introducer, a cutter housing locatednear a distal end of the introducer, and at least one cutter elementrotatably mounted to the cutter housing; (b) rotating the cutterelement; (c) causing the cutter element and soft target tissue to comeinto contact with one another such that the rotating cutter element cutsoff portions of the soft target tissue, the instrument being configuredto cut the tissue in portions having a maximum dimension less than 2 mmacross; and (d) removing the cut tissue portions through a tissueremoval lumen extending from adjacent the cutter element and along theintroducer.

Numerous variations of the tenth aspect of the invention are possibleand include, for example: (1) the cutter element including at least onecutting tooth and at least one trough adjacent the tooth, the at leastone trough having a nominal diameter that is matched to a diameter of afiber or fiber bundle of the target tissue; (2) the cutter elementincluding a plurality of cutting teeth having a pitch that is matched toa diameter of a fiber or fiber bundle of the target tissue; (3) furtherincluding irrigating the at least one rotating cutter element with fluidfrom an irrigation lumen, wherein the irrigation lumen is distinct fromthe tissue removal lumen and extends along the introducer, and whereinthe irrigation lumen has an outlet adjacent to the at least one cutterelement; (4) the elongated introducer having a longitudinal axisextending between the proximal end and the distal end of the introducer,wherein the at least one cutter element has an axis of rotation that isnon-parallel to the longitudinal axis of the introducer; (5) the maximumdimension of the tissue portions being at least one order of magnitudeless than a diameter of the tissue removal lumen; (6) the maximumdimension of the tissue portions being at least twenty times less than adiameter of the tissue removal lumen; (7) the maximum dimension of thetissue portions being less than about 1000 microns; (8) the maximumdimension of the tissue portions being less than about 500 microns; (9)the maximum dimension of the tissue portions being less than about 100microns; (10) the maximum dimension of the tissue portions being about 2microns; (11) only a portion of the cutter element protruding from thehousing; (12) variation (11) wherein the cutter element protrudes fromthe housing less than about 1000 microns; (13) variation (11) whereinthe cutter element protrudes from the housing less than about 500microns; (14) variation (11) wherein the cutter element protrudes fromthe housing less than about 100 microns; (15) variation (11) wherein thecutter element protrudes from the housing less than about 10 microns;(16) the entire cutter element being covered by the housing and aportion of an outer circumference of the cutting element beingsubstantially flush with a tissue access opening in the housing; (17)the entire cutter element being covered by the housing and an outercircumference of the cutting element being recessed within a tissueaccess opening in the housing a minimum of about 10 microns; (18) the atleast one cutter element including at least one rotatably mounted blade,the blade including at least one radially protruding tooth; (19)variation (18) wherein the at least one cutter element further includesat least one radially recessed trough associated with the tooth; and(20) variation (19) wherein the blade trough has a nominal diameter ofless than about 100 microns.

Additional variations of the tenth aspect of the invention are possibleand include, for example: (21) variation (19) wherein the blade troughhas a nominal diameter of about 10 microns; (22) variation (18) whereinthe at least one tooth is configured with a negative angle of attack;(23) variation (18) wherein the at least one tooth is configured with apositive or neutral angle of attack and does not protrude from thehousing; (24) further including altering a parameter of the instrumentafter the rotating cutter element and the soft target tissue are incontact with one another to move the instrument between a first cuttingstate and a second non-cutting state; (25) variation (24) whereinaltering the instrument parameter includes changing an amount of suctionassociated with the tissue removal lumen inlet; (26) variation (24)wherein altering the instrument parameter includes changing the rotationspeed of the at least one blade; (27) variation (24) wherein alteringthe instrument parameter includes changing a rate of aspiration; (28)further including changing a direction of rotation of the cutter elementbetween clockwise and counter-clockwise; (29) the cutter housingincluding two adjacent cutter elements rotatable in opposite directions,each cutter element including at least one blade, the blade or blades ofone cutter element being parallel to, axially offset from, and radiallyoverlapping with the blade or blades of the other cutter element, anaxial clearance between the blades of opposing cutter elements beingless than one fifth of a thickness of the blades; (30) the at least oneblade of each cutter element includes at least one tooth; (31) variation(29) further including rotating one of the cutter elements at a speeddifferent than the speed of the other cutter element; (32) variation(29) wherein each of the cutter elements includes a stack of axiallyaligned blades mounted on an axle, the distance between a maximumdiameter of the blades of one cutter element and the axle of the othercutter element being less than a thickness of the blades; (33) variation(29) wherein each of the cutter elements includes a stack of axiallyaligned blades, wherein a blade of at least one of the cutter elementshas teeth that are rotationally out of phase with the teeth of anotherblade in that cutter element; (34) variation (29) further includingpre-tensioning fibers of the soft target tissue before pulling thefibers between the cutting elements and shearing them from the targettissue, thereby precisely removing of a swath of soft tissue that is atleast as wide as the cutter housing; (35) further including collectingthe cut tissue portions removed through the tissue removal lumen andconducting pathology testing on the tissue portions; (36) furtherincluding collecting the cut tissue portions removed through the tissueremoval lumen and conducting a volume measurement on the tissueportions; (37) further including electronically sensing a transitionfrom one type of tissue being cut to another; (38) variation (37)wherein the electronically sensing step includes monitoring changes incurrent being delivered to a motor that drives the at least one cutterelement; (39) variation (37) wherein the electronically sensing stepincludes monitoring changes or interruptions in a velocity of the atleast one cutter element or a drive system driving the at least onecutter element; and (40) variation (37) wherein the electronicallysensing step includes sensing at least one parameter selected from thegroup consisting of: capacitance, inductance, optical changes, pressure,proximity and position.

An eleventh aspect of the invention provides a method of selectivelyremoving target tissue from a body, including: (a) providing a tissuecutting instrument capable of distinguishing between target tissue to beremoved and non-target tissue; (b) urging the instrument against thetarget tissue and the non-target tissue; and (c) allowing the instrumentto cut the target tissue while automatically avoiding cutting ofnon-target tissue.

Numerous variations of the eleventh aspect of the invention are possibleand include, for example: (1) further including automaticallydiscontinuing tissue cutting once the instrument is contacting onlynon-target tissue; (2) further including allowing the instrument toremove the target tissue from the body as it is being cut; (3) thetissue cutting instrument being configured to distinguish between thetarget tissue and the non-target tissue by sensing an electrical currentlevel being delivered to a cutter motor; (4) the tissue cuttinginstrument being configured to distinguish between the target tissue andthe non-target tissue by electronically sensing a cutter drive velocity;(5) the tissue cutting instrument being configured to sense at least oneparameter selected from the group consisting of: capacitance,inductance, optical changes, pressure, proximity and position; (6) thetissue cutting instrument being configured to allow cutting of thetarget tissue while automatically avoiding cutting of non-target tissueby permitting modulation of a cutter speed; (7) the tissue cuttinginstrument being configured to allow cutting of the target tissue whileautomatically avoiding cutting of non-target tissue by permittingmodulation of suction in a port adjacent to a cutter head of theinstrument; (8) the tissue cutting instrument including cutter elementsthat are tuned to capture elements of the target tissue and rejectelements of the non-target tissue; (9) the tissue cutting instrumentincluding a rotating cutting element covered by a cutter housing, thecutter housing having a tissue access opening adjacent to a portion ofthe cutting element through which tissue must extend to contact thecutting element, the arrangement being configured to allow cutting ofthe target tissue while automatically avoiding cutting of non-targettissue; (10) variation (9) wherein a maximum outside diameter of thecutting element is recessed from the tissue access opening in the cutterhousing; (11) variation (10) wherein the maximum outside diameter isrecessed by about 5 microns; (12) variation (10) wherein the maximumoutside diameter is recessed by about 10 microns; (13) variation (10)wherein the maximum outside diameter is recessed by about 20 microns;(14) variation (10) wherein the maximum outside diameter is recessed byabout 50 microns; (15) variation (10) wherein the maximum outsidediameter is recessed by at least about 100 microns; (16) the instrumentbeing configured to remove a maximum of about 2 microns of target tissueat a time; (17) the instrument being configured to remove a maximum ofabout 5 microns of target tissue at a time; (18) the instrument beingconfigured to remove a maximum of about 10 microns of target tissue at atime; (19) the instrument being configured to remove a maximum of about100 microns of target tissue at a time; and (20) the target tissueincluding endocardium and the non-target tissue includes myocardium.

Additional variations of the eleventh aspect of the invention arepossible and include, for example: (21) the target tissue includingmucosa and the non-target tissue includes submucosa; (22) variation (21)wherein the mucosa and the submucosa are located in an esophagus; (23)the target tissue including flavum and the non-target tissue includingdura mater; (24) the target tissue including flavum and the non-targettissue including nerve roots; (25) the target tissue including flavumand the non-target tissue including bone; (26) the target tissueincluding prostate tissue and the non-target tissue including nervetissue; (27) the target tissue including soft tissue and the non-targettissue including tendon; (28) the target tissue including soft tissueand the non-target tissue including cartilage; (29) the target tissueincluding cartilage and the non-target tissue including bone; (30) thetarget tissue including cancerous cells; (31) variation (30) wherein thenon-target tissue includes vascular tissue; (32) variation (30) whereinthe non-target tissue includes nerve tissue; (33) the target tissueincluding labrum; (34) the target tissue including plaque and thenon-target tissue including a vascular wall; (35) the target tissueincluding calcified tissue and the non-target tissue including avascular wall; (36) the target tissue including a thrombus and thenon-target tissue including a vascular wall; (37) the target tissueincluding a blood clot and the non-target tissue including a vascularwall; (38) the target tissue including an embolus and the non-targettissue including a vascular wall; (39) variation (8) wherein the cutterelements include at least one cutting tooth and at least one troughadjacent the tooth, the at least one trough having a nominal diameterthat is matched to a diameter of a fiber or fiber bundle of the targettissue; and (40) variation (8) wherein the cutter elements include aplurality of cutting teeth having a pitch that is matched to a diameterof a fiber or fiber bundle of the target tissue.

A twelfth aspect of the invention provides a medical device for removingtissue from a subject, including: (a) a distal housing configured withat least one tissue engaging opening; (b) an elongate member coupled tothe distal housing and configured to introduce the distal housing to atarget tissue site of the subject; (c) a first rotatable member locatedat least partially within the distal housing and configured to rotateabout a first axis, the first rotatable member including a firstdisc-shaped blade having a series of teeth along an outer circumferenceof the blade, the first blade lying in a first plane; the firstrotatable member further including a circular first axle portion lyingin a second plane that is offset from, parallel and adjacent to thefirst plane, the first axle portion having an outer circumference thatis smaller than that of the first blade, and (d) a second rotatablemember located at least partially within the distal housing andconfigured to rotate about a second axis parallel to and radially offsetfrom the first axis, the second rotatable member configured to rotate ina direction opposite of a direction of rotation of the first rotatablemember, the second rotatable member including a second disc-shaped bladehaving a series of teeth along an outer circumference of the blade, thesecond blade lying in the second plane, the second rotatable memberfurther including a circular second axle portion lying in the firstplane, the second axle portion having an outer circumference that issmaller than that of the second blade, wherein the first and secondblades are directly adjacent to one another and positioned to partiallyoverlap such that tissue may be sheared between the first and secondblades, between the first blade and the second axle portion and betweenthe second blade and the first axle portion, the rotatable membersconfigured to engage tissue from the target tissue site with the teethof the first and second blades, rotate towards one another and inwardlyto direct tissue from the target tissue site through the tissue engagingopening and into an interior portion of the distal housing.

Numerous variations of the twelfth aspect of the invention are possibleand include, for example: (1) the first rotatable member furtherincluding a third disc-shaped blade having a series of teeth along anouter circumference of the blade, the third blade lying in a third planethat is offset from, parallel and adjacent to the second plane, thesecond rotatable member further including a circular third axle portionlying in the third plane, the third axle portion having an outercircumference that is smaller than that of the third blade, wherein thesecond and third blades are directly adjacent to one another andpositioned to partially overlap such that tissue may be sheared betweenthe second and third blades and between the third blade and the thirdaxle portion, the rotatable members configured to engage tissue from thetarget tissue site with the teeth of the first, second and third blades,rotate towards one another and inwardly to direct tissue from the targettissue site through the tissue engaging opening and into an interiorportion of the distal housing; (2) the distal housing further includinga tissue cutting portion lying in a third plane that is offset from,parallel and adjacent to the second plane, wherein the tissue cuttingportion and the second blade are directly adjacent to one another andpositioned to partially overlap such that tissue may be sheared betweenthe tissue cutting portion of the distal housing and the second blade;(3) the first and second blades being no more than 30 microns apartwhere they partially overlap; (4) the outer circumference of the firstblade being no more than 30 microns apart from the outer circumferenceof the second axle portion, and the outer circumference of the secondblade being no more than 30 microns apart from the outer circumferenceof the first axle portion; (5) the first and the second blades and thefirst and the second axle portions each having a thickness of less than1 mm; (6) the first and the second rotation axes being generallyperpendicular to a longitudinal axis of the elongate member; (7) therotations of the first and the second rotatable members beingsynchronized such that a first trough associated with one of the teethlocated along the outer circumference of the first blade and a secondtrough associated with one of the teeth located along the outercircumference of the second blade simultaneously engage a single fiberor single bundle of fibers from the target tissue site; (8) variation(7) wherein the first and the second troughs cooperate to compressportions of the single fiber or single bundle of fibers as the first andthe second rotatable members rotate toward one another, thereby reducingthe volume of the tissue entering the distal housing; (9) the rotationsof the first and the second rotatable members being configured toalternately rotate in and out of phase with one another; (10) the firstand the second rotatable members being independently driven; (11) thefirst and the second rotatable members being configured to periodicallyreverse direction of rotation during tissue cutting; (12) variation (11)wherein the rotations of the first and the second rotatable members areconfigured to reverse direction at least once per second; (13) variation(11) wherein the device is configured to provide a dwell time of atleast about 50 milliseconds when the first and the second rotatablemembers reverse direction; (14) including fabricating the first bladeand the second axle portion together in a first material depositionprocess step and fabricating the second blade and the first axle portiontogether in a second material deposition process step; and (15)including urging the distal housing of the device against a targettissue site of a subject and extracting cut tissue pieces from aproximal end of the elongate member.

A thirteenth aspect of the invention provides a medical device forremoving tissue from a subject, including: (a) distal housing configuredwith at least one tissue engaging opening; (b) an elongate membercoupled to the distal housing and configured to introduce the distalhousing to a target tissue site of the subject, the elongate memberhaving a central longitudinal axis; (c) a first rotatable member locatedat least partially within the distal housing and configured to rotateabout a singular first axis, the first rotatable member including afirst cutting blade, the first blade having a first side and a secondside opposite the first side; (d) a first tissue shearing surfacelocated and configured to cooperate with the first side of the firstblade to shear tissue therebetween; and (e) a second tissue shearingsurface located and configured to cooperate with the second side of thefirst blade to shear tissue therebetween, the first rotatable memberconfigured to engage tissue from the target tissue site, rotate towardsthe first and second tissue shearing surfaces and inwardly to directtissue from the target tissue site through the tissue engaging openingand into an interior portion of the distal housing.

Numerous variations of the thirteenth aspect of the invention arepossible and include, for example: (1) the first cutting blade includinga disc-shaped portion having a series of teeth along an outercircumference of the blade; (2) variation (1) wherein the disc-shapedportion is perpendicular to the singular first axis; (3) at least one ofthe first and second tissue shearing surfaces being formed by a fixedportion of the distal housing; (4) the first axis of the first rotatablemember being coincident with the longitudinal axis of the elongatemember; (5) the first axis of the first rotatable member intersectingthe longitudinal axis of the elongate member and being perpendiculartherewith; (6) the first axis of the first rotatable member intersectingthe longitudinal axis of the elongate member and forming an angletherewith of between 0 and 90 degrees; (7) the first axis of the firstrotatable member being offset from and parallel to the longitudinal axisof the elongate member and lying in a common plane therewith; (8) thefirst axis of the first rotatable member being offset from andperpendicular to the longitudinal axis of the elongate member and lyingin a common plane therewith; (9) the first axis of the first rotatablemember being offset from the longitudinal axis of the elongate member,lying in a common plane and forming an angle therewith of between 0 and90 degrees; (10) the first axis of the first rotatable member beingoffset from and perpendicular to the longitudinal axis of the elongatemember and lying in a different plane; (11) variation (10) wherein atleast one of the first and second tissue shearing surfaces is formed bya second rotatable member located at least partially within the distalhousing and configured to rotate about a singular second axis parallelto and offset from the first axis, the second rotatable memberconfigured to rotate in a direction opposite of a direction of rotationof the first rotatable member, the second rotatable member including asecond disc-shaped blade having a series of teeth along an outercircumference of the blade; (12) variation (11) wherein the secondrotatable member includes a third disc-shaped blade having a series ofteeth along an outer circumference of the blade, wherein the threeblades are positioned such that they are interdigitated with oneanother; (13) the first axis of the first rotatable member being offsetfrom the longitudinal axis of the elongate member, lying in a differentplane and forming an angle therewith of between 0 and 90 degrees; (14)variation (13) wherein at least one of the first and second tissueshearing surfaces is formed by a second rotatable member located atleast partially within the distal housing and configured to rotate abouta singular second axis parallel to and offset from the first axis, thesecond rotatable member configured to rotate in a direction opposite ofa direction of rotation of the first rotatable member, the secondrotatable member including a second disc-shaped blade having a series ofteeth along an outer circumference of the blade; (15) variation (14)wherein the second rotatable member includes a third disc-shaped bladehaving a series of teeth along an outer circumference of the blade,wherein the three blades are positioned such that they areinterdigitated with one another; (16) the first axis of the firstrotatable member being perpendicular to the longitudinal axis of theelongate member and being configured to articulate with respect thereto;(17) variation (16) wherein the first axis pivots about an articulationaxis that is parallel thereto; (18) variation (16) wherein the firstaxis pivots about an articulation axis that is perpendicular thereto;(19) the elongate member including a distal portion that is oriented atan angle with respect to a more proximal portion of the elongate membersuch that the central longitudinal axis has an inflection point betweenthe distal portion and more proximal portion; (20) variation (19)wherein a distal portion of the central longitudinal axis and a moreproximal portion of the central longitudinal axis lie in a common planethat is coincident with or generally parallel to the first axis of thefirst rotatable member; (21) variation (19) wherein a distal portion ofthe central longitudinal axis and a more proximal portion of the centrallongitudinal axis lie in a common plane that is generally perpendicularto the first axis of the first rotatable member; (22) the elongatemember including a generally rigid, curved distal portion and agenerally straight more proximal portion; (23) variation (22) wherein acurved, distal portion of the central longitudinal axis lies in a planethat is coincident with or generally parallel to the first axis of thefirst rotatable member; and (24) variation (22) wherein a curved distalportion of the central longitudinal axis lies in a plane that isgenerally perpendicular to the first axis of the first rotatable member.

A fourteenth aspect of the invention provides a medical device forremoving tissue from a subject, including: (a) a distal housingconfigured with a tissue cutter assembly; (b) an elongate member coupledto the distal housing and configured to introduce the distal housing toa target tissue site of the subject, the elongate member having an outertube, an inner drive tube rotatably mounted within the outer tube, andan annular void formed between the inner drive tube and the outer tube,wherein the outer tube and the distal housing form a stator assembly;(c) a coupler located at a distal end of the inner drive tube androtationally coupled therewith to form a rotor assembly, the couplerconfigured to engage with the tissue cutter assembly to rotatably drivethe tissue cutter assembly, the coupler having a rear thrust surfaceconfigured to cooperate with a first surface on the stator assembly toprevent the inner drive tube from moving proximally beyond apredetermined rear location, the coupler having a forward thrust surfaceconfigured to cooperate with a second surface on the stator assembly toprevent the inner drive tube from moving distally beyond a predeterminedforward location; and (d) a commutator portion located between the rotorassembly and the stator assembly, the commutator portion having at leastone solid region configured to rotatably support the rotor assemblyrelative to the stator assembly, the commutator portion having at leastone fluid channel configured to allow passage of a fluid from theannular void, distally across the commutator portion, and into a firstfluid plenum adjacent to the rear thrust surface and the first surfaceof the stator assembly; wherein the coupler and the distal housing format least one passage therebetween that fluidically connects the firstfluid plenum with a second fluid plenum adjacent to the forward thrustsurface and the second surface of the stator assembly; and wherein thedevice is configured to allow a fluid to flow distally through theannular void, through the at least one fluid channel in the commutatorportion, through the first fluid plenum, through the at least onepassage between the coupler and the distal housing, through the secondfluid plenum, into at least a portion of the tissue cutter assembly, andproximally through the inner drive tube, wherein the device isconfigured to allow the fluid to lubricate and cool the forward and rearthrust surfaces and the tissue cutter assembly, and to transport tissuepieces cut by the tissue cutter assembly proximally through the innerdrive tube.

Numerous variations of the fourteenth aspect of the invention arepossible and include, for example: (1) the commutator portion beinglocated on the coupler; (2) the commutator portion being located on thedistal housing; (3) the commutator portion being located on both thecoupler and the distal housing; (4) the commutator portion including aradially outwardly protruding bearing surface configured to rotaterelative to and bear against a portion of the stator assembly, and aradially inwardly protruding surface at least partially defining the atleast one fluid channel across the commutator portion; (5) the couplerbeing integrally formed on the distal end of the inner drive tube; (6)the coupler being a separate piece attached to the distal end of theinner drive tube; (7) the rotor assembly including a third plenumaxially located between the first plenum and the second plenum; (8)variation (7) wherein the third plenum is formed in the coupler andencircles the coupler; (9) variation (7) wherein the third plenum isformed in the distal housing and encircles the distal housing; (10) theinner drive tube having a proximal end that is axially unconstrained sothat it may move axially relative to a proximal end of the outer tube;(11) at least a portion of both the inner drive tube and outer tubebeing bendable; (12) variation (11) wherein at least a portion of atleast one of the inner drive tube and outer tube is malleable; (13) afirst portion of the elongate member telescoping within a second portionof the elongate member; (14) a first portion of the elongate memberarticulating around at least one transverse pivot axis relative to asecond portion of the elongate member.

A fifteenth aspect of the invention provides a medical device forremoving tissue from a subject, including: (a) a distal housingconfigured with a tissue cutter assembly; (b) an elongate member coupledto the distal housing and configured to introduce the distal housing toa target tissue site of the subject, the elongate member having an outertube, an inner drive tube rotatably mounted within the outer tube, andan annular void formed between the inner drive tube and the outer tube,wherein the outer tube and the distal housing form a stator assembly;(c) a crown gear located on a distal end of the inner drive tube, thecoupler configured to engage a right angle gear of the tissue cutterassembly to rotatably drive the tissue cutter assembly; (d) a thrustring rigidly affixed around the inner drive tube near the distal end ofthe drive tube, the thrust ring having a rear thrust surface configuredto cooperate with a first surface on the stator assembly to prevent theinner drive tube from moving proximally beyond a predetermined rearlocation; and (e) a commutator portion located between the inner drivetube and the stator assembly, the commutator portion having at least onesolid region configured to rotatably support the inner drive tuberelative to the stator assembly, the commutator portion having at leastone fluid channel configured to allow passage of a fluid from theannular void, distally across the commutator portion, and into a firstfluid plenum adjacent to the rear thrust surface and the first surfaceof the stator assembly; wherein the thrust ring and the distal housingform at least one passage therebetween that is in fluid communicationwith the first fluid plenum; wherein the device is configured to allow afluid to flow distally through the annular void, through the at leastone fluid channel in the commutator portion, through the first fluidplenum, through the at least one passage between the thrust ring and thedistal housing, into at least a portion of the tissue cutter assembly,and proximally through the inner drive tube; and wherein the device isconfigured to allow the fluid to lubricate and cool the rear thrustsurface and the tissue cutter assembly, and to transport tissue piecescut by the tissue cutter assembly proximally through the inner drivetube.

Numerous variations of the fifteenth aspect of the invention arepossible and include, for example: (1) the commutator portion beinglocated on the distal housing; (2) the commutator portion including aradially inwardly protruding bearing surface configured to bear againsta portion of the inner drive tube, thereby radially constraining theinner drive tube while permitting it to freely rotate, and a radiallyoutwardly protruding surface at least partially defining the at leastone fluid channel across the commutator portion; (3) the thrust ringbeing rigidly affixed to the inner drive tube with at least one weldmentinside a preformed hole through a wall of the thrust ring; (4) the firstfluid plenum being formed in the distal housing and encircling thedistal housing; (5) the crown gear and the right angle gear beingconfigured to cooperate to prevent the inner drive tube from movingdistally beyond a predetermined forward location; (6) the tissue cutterassembly including a first rotor and a second, oppositely rotatingrotor, each of the first and second rotors configured to rotate about anaxis that is perpendicular to a central longitudinal axis of theelongate member, each of the first and second rotors having a pluralityof blades, wherein the blades of the first rotor are configured tointerdigitate with the blades of second rotor; (7) the inner drive tubehaving a proximal end that is axially unconstrained so that it may moveaxially relative to a proximal end of the outer tube; (8) at least aportion of both the inner drive tube and outer tube being bendable; (9)variation (8) wherein at least a portion of at least one of the innerdrive tube and outer tube is malleable; (10) a first portion of theelongate member telescoping within a second portion of the elongatemember; and (11) a first portion of the elongate member articulatingaround at least one transverse pivot axis relative to a second portionof the elongate member.

A sixteenth aspect of the invention provides a medical device forremoving tissue from a subject, including: (a) a distal housingconfigured with a tissue cutter assembly; (b) an elongate member coupledto the distal housing and configured to introduce the distal housing toa target tissue site of the subject, the elongate member having an outertube, an inner drive tube rotatably mounted within the outer tube, theinner drive tube having a crown gear located on a distal end thereof;(c) a first rotatable member and a second rotatable member eachrotatably mounted to the tissue cutter assembly, the first and thesecond rotatable members each including a plurality of disc shapedblades, wherein each of the plurality of blades of the first rotatablemember lies in a plane parallel to and axially offset from a plane ofanother of the blades of the first rotatable member, wherein each of theplurality of blades of the first and the second rotatable members aredirectly adjacent to at least one parallel surface and positioned topartially overlap the adjacent parallel surface such that tissue may besheared between the adjacent, overlapping blades and parallel surfacesand such that the first and the second rotatable members are configuredto rotate and direct tissue into an interior portion of the distalhousing; (d) a first drive gear train coupled between the crown gear andthe first rotatable member, the first drive gear train including atleast one spur gear; and (e) a second drive gear train coupled betweenthe crown gear and the second rotatable member, the second drive geartrain including at least one spur gear; wherein the first and the seconddrive gear trains are configured to drive the first and the secondrotatable members, respectively, in opposite directions.

Numerous variations of the sixteenth aspect of the invention arepossible and include, for example: (1) the first and the second drivegear trains each including two separate spur gears; (2) variation (1)wherein the two separate spur gears of the first drive gear train arearranged in a symmetrical fashion relative to the two separate spurgears of the second drive gear train; (3) the tissue cutter assemblybeing fabricated separately from the distal housing and subsequentlyassembled therewith; (4) variation (3) wherein the tissue cutterassembly is formed at least in part by an additive process, and whereinthe distal housing is formed at least in part by a subtractive process;and (5) the elongate member including an annular void formed between theinner drive tube and the outer tube, and the device being configured tohave irrigation fluid flow distally through the annular void, throughthe tissue cutter assembly, and then carry cut tissue pieces proximallythough the inner drive tube.

A seventeenth aspect of the invention provides a medical device forremoving tissue from a subject, including: (a) a distal housingconfigured with a tissue cutter assembly; (b) an elongate member coupledto the distal housing and configured to introduce the distal housing toa target tissue site of the subject, the elongate member having an outertube, an inner drive tube rotatably mounted within the outer tube, theinner drive tube having a crown gear located on a distal end thereof andincluding a plurality of gear teeth, the inner drive tube having anouter diameter no greater than 12 mm and no smaller than 0.5 mm; (c) afirst rotatable member and a second rotatable member each rotatablymounted to the tissue cutter assembly, the first and the secondrotatable members each including a plurality of disc shaped blades,wherein each of the plurality of blades of the first rotatable memberlies in a plane parallel to and axially offset from a plane of anotherof the blades of the first rotatable member; wherein each of theplurality of blades of the first and the second rotatable members aredirectly adjacent to at least one parallel surface and positioned topartially overlap the adjacent parallel surface such that tissue may besheared between the adjacent, overlapping blades and parallel surfacesand such that the first and the second rotatable members are configuredto rotate in opposite directions to direct tissue into an interiorportion of the distal housing; and (d) a first drive gear train coupledbetween the crown gear and the first rotatable member, the first drivegear train including a first spur gear having a plurality of gear teetharranged to mesh with the gear teeth of the crown gear, the first spurgear being configured to rotate about an axis that is not parallel to anaxis of rotation of the crown gear, wherein the crown gear teeth have aconvex profile and the first spur gear teeth have a concave profile.

Numerous variations of the seventeenth aspect of the invention arepossible and include, for example: (1) the crown gear teeth having amid-point base thickness that is greater than a base thickness of thefirst spur gear teeth; (2) variation (1) wherein the ratio of the firstspur gear teeth mid-point base thickness to the crown gear teethmid-point base thickness is in the range of 0.6 to 0.9; (3) variation(2) wherein the ratio is about 0.76; (4) the first drive gear trainincluding a second spur gear coupled between the first spur gear and thefirst rotatable member, the second spur gear having teeth with a convexprofile; (5) variation (4) wherein the second spur gear teeth have amid-point base thickness that is greater than a mid-point base thicknessof the first spur gear teeth; (6) variation (5) wherein the ratio of thefirst spur gear teeth mid-point base thickness to the second spur gearteeth mid-point base thickness is in the range of 0.4 to 0.95; (7)variation (6) wherein the ratio is about 0.85; (8) variation (5) whereina tangent to a mid-point base thickness of the teeth of the second spurgear slopes towards a tip of the teeth of the second spur gear; (9)variation (5) wherein a tangent to a mid-point base thickness of theteeth of the second spur gear slopes away from a tip of the teeth of thesecond spur gear to create a bulging tip section of the teeth of thesecond spur gear to reduce backlash between the teeth of second spurgear and the teeth of the first spur gear; (10) variation (9) whereinthe ratio of the first spur gear teeth mid-point base thickness to thesecond spur gear teeth mid-point base thickness is in the range of 0.6to 0.9; (11) variation (10) wherein the ratio is about 0.77; (12) thecrown gear teeth having opposing side surfaces that taper towards acenter point of the inner drive tube; (13) both the first and the secondrotatable members being driven by the first drive gear train; and (14)further including a second drive gear train coupled between the crowngear and the second rotatable member, the second drive gear trainincluding a second spur gear having a plurality of gear teeth arrangedto mesh with the gear teeth of the crown gear, the second spur gearbeing configured to rotate about an axis that is not parallel to an axisof rotation of the crown gear, wherein the second spur gear teeth have aconcave profile.

An eighteenth aspect of the invention provides a medical device forremoving tissue from a subject, including: (a) a distal housingconfigured with a tissue cutter assembly; (b) an elongate member coupledto the distal housing and configured to introduce the distal housing toa target tissue site of the subject, the elongate member having an outertube, an inner drive tube rotatably mounted within the outer tube, theinner drive tube having a crown gear located on a distal end thereof andincluding a plurality of gear teeth, wherein the crown gear teeth haveopposing side surfaces that taper towards a center point of the innerdrive tube, the inner drive tube having an outer diameter no greaterthan 12 mm and no smaller than 0.5 mm; (c) a first rotatable member anda second rotatable member each rotatably mounted to the tissue cutterassembly, the first and the second rotatable members each including aplurality of disc shaped blades, wherein each of the plurality of bladesof the first rotatable member lies in a plane parallel to and axiallyoffset from a plane of another of the blades of the first rotatablemember, wherein each of the plurality of blades of the first and thesecond rotatable members are directly adjacent to at least one parallelsurface and positioned to partially overlap the adjacent parallelsurface such that tissue may be sheared between the adjacent,overlapping blades and parallel surfaces and such that the first and thesecond rotatable members are configured to rotate in opposite directionsto direct tissue into an interior portion of the distal housing; (d) afirst drive gear train coupled between the crown gear and the firstrotatable member, the first drive gear train including a first spur gearhaving a plurality of gear teeth arranged to mesh with the gear teeth ofthe crown gear and a second spur gear having a plurality of gear teetharranged to mesh with the gear teeth of the first spur gear, the firstand the second spur gears being configured to rotate about axes that areperpendicular to an axis of rotation of the crown gear, wherein thecrown gear teeth and the second spur gear teeth have a convex profileand the first spur gear teeth have a concave profile, wherein the crowngear teeth and the second spur gear teeth have a mid-point basethickness that is greater than a base thickness of the first spur gearteeth; and (e) a second drive gear train coupled between the crown gearand the second rotatable member, the second drive gear train including athird spur gear having a plurality of gear teeth arranged to mesh withthe gear teeth of the crown gear and a fourth spur gear having aplurality of gear teeth arranged to mesh with the gear teeth of thethird spur gear, the third and the fourth spur gears being configured torotate about axes that are perpendicular to the axis of rotation of thecrown gear, wherein the fourth spur gear teeth have a convex profile andthe third spur gear teeth have a concave profile, wherein the crown gearteeth and the fourth spur gear teeth have a mid-point base thicknessthat is greater than a base thickness of the third spur gear teeth.

A variation of the eighteenth aspect of the invention is possible andincludes, for example, a tangent to a mid-point base thickness of theteeth of the second spur gear sloping away from a tip of the teeth ofthe second spur gear to create a bulging tip section of the teeth of thesecond spur gear to reduce backlash between the teeth of second spurgear and the teeth of the first spur gear, and a tangent to a mid-pointbase thickness of the teeth of the fourth spur gear sloping away from atip of the teeth of the fourth spur gear to create a bulging tip sectionof the teeth of the fourth spur gear to reduce backlash between theteeth of fourth spur gear and the teeth of the third spur gear.

The disclosure of the present invention provides numerous deviceembodiments wherein the devices may be formed, in whole or in part,using a multi-layer, multi-material fabrication process wherein eachsuccessively formed layer comprises at least two materials, one of whichis a structural material and the other of which is a sacrificialmaterial, and wherein each successive layer defines a successivecross-section of the three-dimensional structure, and wherein theforming of each of the plurality of successive layers includes: (i)depositing a first of the at least two materials; (ii) depositing asecond of the at least two materials; and (B) after the forming of theplurality of successive layers, separating at least a portion of thesacrificial material from the structural material to reveal thethree-dimensional structure.

Other aspects of the invention will be understood by those of skill inthe art upon review of the teachings herein. Other aspects of theinvention may involve combinations of the above noted aspects orvariations of aspects of the invention. It is intended that variationsof one aspect of the invention may be applied to other aspects of theinvention and that various features of one or more aspects of theinvention be useable in other aspects of the invention and even thatsub-combinations of various features of one or more aspects of theinvention may provide new aspects of the invention. Combinations areconsidered appropriate so long as the combinations do not remove allfunctionality provided by individual components. These other aspects ofthe invention may provide various combinations and sub-combination ofthe aspects presented above as well as provide other configurations,structures, functional relationships, processes for making, and/orprocedures for using that have not been specifically set forth above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C schematically depict side views of various stages of a CCmask plating process, while FIGS. 1D-G schematically depict a side viewsof various stages of a CC mask plating process using a different type ofCC mask.

FIGS. 2A-2F schematically depict side views of various stages of anelectrochemical fabrication process as applied to the formation of aparticular structure where a sacrificial material is selectivelydeposited while a structural material is blanket deposited.

FIGS. 3A-3C schematically depict side views of various examplesubassemblies that may be used in manually implementing theelectrochemical fabrication method depicted in FIGS. 2A-2F.

FIGS. 4A-4F schematically depict the formation of a first layer of astructure using adhered mask plating where the blanket deposition of asecond material overlays both the openings between deposition locationsof a first material and the first material itself

FIG. 4G depicts the completion of formation of the first layer resultingfrom planarizing the deposited materials to a desired level.

FIGS. 4H and 4I respectively depict the state of the process afterformation of the multiple layers of the structure and after release ofthe structure from the sacrificial material.

FIGS. 5-7 illustrate an exemplary embodiment of a working end of atissue removal device which can be fabricated wholly or in part byelectrochemical fabrication techniques, such as those described orreferenced herein.

FIG. 8 illustrates a perspective view of an exemplary gear train systemwhich can be included in any suitable working end described herein todrive the rotation of the blades.

FIG. 9 shows a portion of two adjacent gears formed from a multi-layer,multi-material electrochemical fabrication process.

FIG. 10 illustrates an exemplary embodiment of a first gearconfiguration for assembled fabrication which allows for minimizingbacklash while still meeting minimum feature size limitations in bothgear tooth spacing as well as axle shaft and guide hole, bearing orbushing spacing.

FIGS. 11 and 12 show three gears in an “as fabricated” configuration.

FIGS. 13 and 14 highlight the proximal end and distal end, respectively,of the gear trains shown in FIG. 8, which incorporate a multi-tieredgear design.

FIG. 15 illustrates an alternative embodiment of a gear formation thatcan be used in any of the tissue removal devices herein.

FIGS. 16-19 illustrate yet another alternative gear train design whichmay allow meeting minimum feature size requirements while providing morerobust gears along with back lash not being excessively large.

FIG. 20 illustrates a partial view of the working end of tissue removaldevice in which the top portion and one side wall of housing have beenremoved to show one of the exemplary gear trains from FIG. 8 disposed inhousing.

FIG. 21 provides a perspective cross-sectional view of the rear portionof a working end of a device according to an embodiment of thedisclosure with the back shielding and a portion of the gears cut awayso that the relationship between the gears, the upper and lower gearenclosures, and outer housing of the device can be seen.

FIG. 22 illustrates an alternative drive mechanism coupler having aD-shaped hole or bore.

FIGS. 23A-27C illustrate alternative exemplary embodiments of drivemechanisms which can power the drive trains in the working end, any ofwhich may be adapted to be included in any suitable tissue removaldevice, such as those described herein.

FIG. 28 illustrates an exemplary coupling between an introducer and aworking end, wherein the introducer is adapted to introduce, orposition, the working end at the target tissue site.

FIG. 29 illustrates an exemplary articulatable introducer includingnon-articulating portion and articulating portion, wherein theintroducer is coupled to working end.

FIG. 30 shows an introducer and a working end, including shredders,coupled together, with a portion of introducer disposed within adelivery member.

FIG. 31A illustrates a portion of a housing of a working end, includingfixed tissue removal elements, an optional irrigation port, and aslidable element disposed within a bore in a housing.

FIG. 31B shows an exemplary embodiment of a working end that is adaptedto be actuated to rotate a working end relative to an introducer.

FIGS. 32A-32C illustrate a device and methods for providing a space forvisualization of the target site, and/or target tissue.

FIGS. 33A-33C illustrate an alternative arrangement of the deliverysystem for visualizing the working area.

FIG. 34A-34E illustrate an exemplary procedure for treating a herniateddisc by removing nucleus tissue using a tissue removal device asdescribed herein.

FIG. 35 illustrates an exemplary embodiment wherein the axes of rotationof the rotors for a set of blades are substantially orthogonal to thelongitudinal axis of at least the working end.

FIG. 36 shows a distal end of a working end including a single rotor andstator wherein the stator includes fingers or other elements that workwith the rotor to cause shredding or other disruption of the tissue intosmall pieces that may be removed via the device from the body of apatient.

FIG. 37 shows exemplary blade profiles for removing soft tissue.

FIG. 38 shows some additional exemplary blade types, supplementing someof the blade types shown in FIG. 37.

FIGS. 39A-39C illustrate exemplary embodiments of double rotor bladedesigns.

FIGS. 40A (perspective view) and 40B (top view) illustrate analternative embodiment of a working end in which tissue is captured andprocessed in multiple steps.

FIG. 41 illustrates an alternative design in which a plurality of bladerotors directs tissue (not shown) towards a set of vertical cutterswhich are fixed in place.

FIG. 42 shows an alternative embodiment of a ‘hybrid’ blade with teeththat are capable of both piercing and cutting into tissue to entrain it.

FIG. 43 illustrates an optional blade stagger design in which the tipsof teeth are staggered from one another as measured circumferentially orin an offset angular increment relative to adjacent blade tips.

FIG. 44 illustrates an exemplary embodiment of components of a devicethat are formed in one configuration but separated from a finalconfiguration and are moved relatively toward one another after releasefrom sacrificial material.

FIG. 45 shows an exemplary embodiment in which a gear or boss isfabricated in an “as-formed” configuration in which it is out of planewith material which the gear or boss will ultimately be in-plane with ina final configuration after formation.

FIG. 46 illustrates an alternative embodiment similar to FIG. 44,wherein a slide plate includes a protrusion on one side adapted to fitwithin a channel

FIGS. 47A-47C illustrate an exemplary embodiment of a working endincluding a gear train and two shredder rotors.

FIGS. 48A-48C illustrate an embodiment of a tissue removal deviceincluding a core cutting saw 740 with a plurality of tissue removaldevices 742 therein.

FIG. 49 provides a schematic illustration of a plurality (i.e. 5 asshown) stacked tissue shredding devices having individual and stackedconfigurations providing a large area tissue removal surface having adesired configuration (e.g. circular configuration).

FIGS. 50A and 50B provide a schematic illustration of a shredding ortissue removal device, i.e. working end, located within a lumen havingan expanded distal end and a smaller lumen which may be used to feedadditional tools or elements into or beyond the expanded distal end ofthe lumen.

FIGS. 51A and 51B provide closed (compacted) and open (expanded) viewsof a sample device according to a procedural embodiment of thedisclosure.

FIGS. 52A-52F illustrate the use of the devices of FIGS. 50A-50B and51A-51B in a thrombectomy application.

FIGS. 53A-53D show another exemplary embodiment of a tissue removaldevice.

FIGS. 54A-54C show an exemplary cutter head assembly 5332 that may beused with debriding device 5310, shown in FIGS. 53A-53D.

FIGS. 55A-55D show further details of the lug bearing of cutter headassembly 5332, shown in FIGS. 54A-54C.

FIGS. 56A-56H show further details of cutter head assembly 5332, shownin FIGS. 54A-54C.

FIGS. 57A-57J show details of an exemplary rotor housing assembly 5420′.

FIGS. 58-65 depict various other aspects of cutting blades useful forselective tissue removal, according to aspects of the present invention.

FIGS. 66A-66M show views of 13 more examples of cutter heads constructedaccording to aspects of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Electrochemical Fabrication in General

FIGS. 1A-1G, 2A-2F, and 3A-3C illustrate various features of one form ofelectrochemical fabrication. Other electrochemical fabricationtechniques are set forth in the '630 patent referenced above, in thevarious previously incorporated publications, in various other patentsand patent applications incorporated herein by reference. Still othersmay be derived from combinations of various approaches described inthese publications, patents, and applications, or are otherwise known orascertainable by those of skill in the art from the teachings set forthherein. All of these techniques may be combined with those of thevarious embodiments of various aspects of the disclosure to yieldenhanced embodiments. Still other embodiments may be derived fromcombinations of the various embodiments explicitly set forth herein.

FIGS. 4A-4I illustrate various stages in the formation of a single layerof a multi-layer fabrication process where a second metal is depositedon a first metal as well as in openings in the first metal so that thefirst and second metal form part of the layer. In FIG. 4A a side view ofa substrate 82 is shown, onto which patternable photoresist 84 is castas shown in FIG. 4B. In FIG. 4C, a pattern of resist is shown thatresults from the curing, exposing, and developing of the resist. Thepatterning of the photoresist 84 results in openings or apertures92(a)-92(c) extending from a surface 86 of the photoresist through thethickness of the photoresist to surface 88 of the substrate 82. In FIG.4D a metal 94 (e.g. nickel) is shown as having been electroplated intothe openings 92(a)-92(c). In FIG. 4E the photoresist has been removed(i.e. chemically stripped) from the substrate to expose regions of thesubstrate 82 which are not covered with the first metal 94. In FIG. 4F asecond metal 96 (e.g. silver) is shown as having been blanketelectroplated over the entire exposed portions of the substrate 82(which is conductive) and over the first metal 94 (which is alsoconductive). FIG. 4G depicts the completed first layer of the structurewhich has resulted from the planarization of the first and second metalsdown to a height that exposes the first metal and sets a thickness forthe first layer. In FIG. 4H the result of repeating the process stepsshown in FIGS. 4B-4 G several times to form a multi-layer structure areshown where each layer consists of two materials. For most applications,one of these materials is removed as shown in FIG. 4I to yield a desired3-D structure 98 (e.g. component or device).

Various embodiments of various aspects of the disclosure are directed toformation of three-dimensional structures from materials some of whichmay be electrodeposited or electroless deposited. Some of thesestructures may be formed form a single build level formed from one ormore deposited materials while others are formed from a plurality ofbuild layers each including at least two materials (e.g. two or morelayers, more preferably five or more layers, and most preferably ten ormore layers). In some embodiments, layer thicknesses may be as small asone micron or as large as fifty microns. In other embodiments, thinnerlayers may be used while in other embodiments, thicker layers may beused. In some embodiments structures having features positioned withmicron level precision and minimum features size on the order of tens ofmicrons are to be formed. In other embodiments structures with lessprecise feature placement and/or larger minimum features may be formed.In still other embodiments, higher precision and smaller minimum featuresizes may be desirable. In the present application meso-scale andmillimeter scale have the same meaning and refer to devices that mayhave one or more dimensions extending into the 0.5-20 millimeter range,or somewhat larger and with features positioned with precision in the10-100 micron range and with minimum features sizes on the order of 100microns.

The various embodiments, alternatives, and techniques disclosed hereinmay form multi-layer structures using a single patterning technique onall layers or using different patterning techniques on different layers.For example, various embodiments of the disclosure may perform selectivepatterning operations using conformable contact masks and maskingoperations (i.e. operations that use masks which are contacted to butnot adhered to a substrate), proximity masks and masking operations(i.e. operations that use masks that at least partially selectivelyshield a substrate by their proximity to the substrate even if contactis not made), non-conformable masks and masking operations (i.e. masksand operations based on masks whose contact surfaces are notsignificantly conformable), and/or adhered masks and masking operations(masks and operations that use masks that are adhered to a substrateonto which selective deposition or etching is to occur as opposed toonly being contacted to it). Conformable contact masks, proximity masks,and non-conformable contact masks share the property that they arepreformed and brought to, or in proximity to, a surface which is to betreated (i.e. the exposed portions of the surface are to be treated).These masks can generally be removed without damaging the mask or thesurface that received treatment to which they were contacted, or locatedin proximity to. Adhered masks are generally formed on the surface to betreated (i.e. the portion of that surface that is to be masked) andbonded to that surface such that they cannot be separated from thatsurface without being completely destroyed damaged beyond any point ofreuse. Adhered masks may be formed in a number of ways including (1) byapplication of a photoresist, selective exposure of the photoresist, andthen development of the photoresist, (2) selective transfer ofpre-patterned masking material, and/or (3) direct formation of masksfrom computer controlled depositions of material.

Patterning operations may be used in selectively depositing materialand/or may be used in the selective etching of material. Selectivelyetched regions may be selectively filled in or filled in via blanketdeposition, or the like, with a different desired material. In someembodiments, the layer-by-layer build up may involve the simultaneousformation of portions of multiple layers. In some embodiments,depositions made in association with some layer levels may result indepositions to regions associated with other layer levels (i.e. regionsthat lie within the top and bottom boundary levels that define adifferent layer's geometric configuration). Such use of selectiveetching and interlaced material deposition in association with multiplelayers is described in the '519 application set forth in the tablebelow, which is hereby incorporated herein by reference as if set forthin full.

Temporary substrates on which structures may be formed may be of thesacrificial-type (i.e. destroyed or damaged during separation ofdeposited materials to the extent they cannot be reused),non-sacrificial-type (i.e. not destroyed or excessively damaged, i.e.not damaged to the extent they may not be reused, e.g. with asacrificial or release layer located between the substrate and theinitial layers of a structure that is formed). Non-sacrificialsubstrates may be considered reusable, with little or no rework (e.g.replanarizing one or more selected surfaces or applying a release layer,and the like) though they may or may not be reused for a variety ofreasons.

Definitions

This section of the specification is intended to set forth definitionsfor a number of specific terms that may be useful in describing thesubject matter of the various embodiments of the disclosure describedherein. It is believed that the meanings of most if not all of theseterms is clear from their general use in the specification but they areset forth hereinafter to remove any ambiguity that may exist. It isintended that these definitions be used in understanding the scope andlimits of any claims that use these specific terms. As far asinterpretation of the claims of this patent disclosure are concerned, itis intended that these definitions take precedence over anycontradictory definitions or allusions found in any materials which areincorporated herein by reference.

“Build” as used herein refers, as a verb, to the process of building adesired structure or plurality of structures from a plurality of appliedor deposited materials which are stacked and adhered upon application ordeposition or, as a noun, to the physical structure or structures formedfrom such a process. Depending on the context in which the term is used,such physical structures may include a desired structure embedded withina sacrificial material or may include only desired physical structureswhich may be separated from one another or may require dicing and/orslicing to cause separation.

“Build axis” or “build orientation” is the axis or orientation that issubstantially perpendicular to substantially planar levels of depositedor applied materials that are used in building up a structure. Theplanar levels of deposited or applied materials may be or may not becompletely planar but are substantially so in that the overall extent oftheir cross-sectional dimensions are significantly greater than theheight of any individual deposit or application of material (e.g. 100,500, 1000, 5000, or more times greater). The planar nature of thedeposited or applied materials may come about from use of a process thatleads to planar deposits or it may result from a planarization process(e.g. a process that includes mechanical abrasion, e.g. lapping, flycutting, grinding, or the like) that is used to remove material regionsof excess height. Unless explicitly noted otherwise, “vertical” as usedherein refers to the build axis or nominal build axis (if the layers arenot stacking with perfect registration) while “horizontal” refers to adirection within the plane of the layers (i.e. the plane that issubstantially perpendicular to the build axis).

“Build layer” or “layer of structure” as used herein does not refer to adeposit of a specific material but instead refers to a region of a buildlocated between a lower boundary level and an upper boundary level whichgenerally defines a single cross-section of a structure being formed orstructures which are being formed in parallel. Depending on the detailsof the actual process used to form the structure, build layers aregenerally formed on and adhered to previously formed build layers. Insome processes the boundaries between build layers are defined byplanarization operations which result in successive build layers beingformed on substantially planar upper surfaces of previously formed buildlayers. In some embodiments, the substantially planar upper surface ofthe preceding build layer may be textured to improve adhesion betweenthe layers. In other build processes, openings may exist in or be formedin the upper surface of a previous but only partially formed buildlayers such that the openings in the previous build layers are filledwith materials deposited in association with current build layers whichwill cause interlacing of build layers and material deposits. Suchinterlacing is described in the '519 application set forth in the tablebelow. This referenced application is incorporated herein by referenceas if set forth in full. In most embodiments, a build layer includes atleast one primary structural material and at least one primarysacrificial material. However, in some embodiments, two or more primarystructural materials may be used without a primary sacrificial material(e.g. when one primary structural material is a dielectric and the otheris a conductive material). In some embodiments, build layers aredistinguishable from each other by the source of the data that is usedto yield patterns of the deposits, applications, and/or etchings ofmaterial that form the respective build layers. For example, datadescriptive of a structure to be formed which is derived from dataextracted from different vertical levels of a data representation of thestructure define different build layers of the structure. The verticalseparation of successive pairs of such descriptive data may define thethickness of build layers associated with the data. As used herein, attimes, “build layer” may be loosely referred simply as “layer”. In manyembodiments, deposition thickness of primary structural or sacrificialmaterials (i.e. the thickness of any particular material after it isdeposited) is generally greater than the layer thickness and a netdeposit thickness is set via one or more planarization processes whichmay include, for example, mechanical abrasion (e.g. lapping, flycutting, polishing, and the like) and/or chemical etching (e.g. usingselective or non-selective etchants). The lower boundary and upperboundary for a build layer may be set and defined in different ways.From a design point of view they may be set based on a desired verticalresolution of the structure (which may vary with height). From a datamanipulation point of view, the vertical layer boundaries may be definedas the vertical levels at which data descriptive of the structure isprocessed or the layer thickness may be defined as the height separatingsuccessive levels of cross-sectional data that dictate how the structurewill be formed. From a fabrication point of view, depending on the exactfabrication process used, the upper and lower layer boundaries may bedefined in a variety of different ways. For example by planarizationlevels or effective planarization levels (e.g. lapping levels, flycutting levels, chemical mechanical polishing levels, mechanicalpolishing levels, vertical positions of structural and/or sacrificialmaterials after relatively uniform etch back following a mechanical orchemical mechanical planarization process). For example, by levels atwhich process steps or operations are repeated. At levels at which, atleast theoretically, lateral extends of structural material can bechanged to define new cross-sectional features of a structure.

“Layer thickness” is the height along the build axis between a lowerboundary of a build layer and an upper boundary of that build layer.

“Planarization” is a process that tends to remove materials, above adesired plane, in a substantially non-selective manner such that alldeposited materials are brought to a substantially common height ordesired level (e.g. within 20%, 10%, 5%, or even 1% of a desired layerboundary level). For example, lapping removes material in asubstantially non-selective manner though some amount of recession onematerial or another may occur (e.g. copper may recess relative tonickel). Planarization may occur primarily via mechanical means, e.g.lapping, grinding, fly cutting, milling, sanding, abrasive polishing,frictionally induced melting, other machining operations, or the like(i.e. mechanical planarization). Mechanical planarization maybe followedor proceeded by thermally induced planarization (.e.g. melting) orchemically induced planarization (e.g. etching). Planarization may occurprimarily via a chemical and/or electrical means (e.g. chemical etching,electrochemical etching, or the like). Planarization may occur via asimultaneous combination of mechanical and chemical etching (e.g.chemical mechanical polishing (CMP)).

“Structural material” as used herein refers to a material that remainspart of the structure when put into use.

“Supplemental structural material” as used herein refers to a materialthat forms part of the structure when the structure is put to use but isnot added as part of the build layers but instead is added to aplurality of layers simultaneously (e.g. via one or more coatingoperations that applies the material, selectively or in a blanketfashion, to a one or more surfaces of a desired build structure that hasbeen released from a sacrificial material.

“Primary structural material” as used herein is a structural materialthat forms part of a given build layer and which is typically depositedor applied during the formation of that build layer and which makes upmore than 20% of the structural material volume of the given buildlayer. In some embodiments, the primary structural material may be thesame on each of a plurality of build layers or it may be different ondifferent build layers. In some embodiments, a given primary structuralmaterial may be formed from two or more materials by the alloying ordiffusion of two or more materials to form a single material.

“Secondary structural material” as used herein is a structural materialthat forms part of a given build layer and is typically deposited orapplied during the formation of the given build layer but is not aprimary structural material as it individually accounts for only a smallvolume of the structural material associated with the given layer. Asecondary structural material will account for less than 20% of thevolume of the structural material associated with the given layer. Insome preferred embodiments, each secondary structural material mayaccount for less than 10%, 5%, or even 2% of the volume of thestructural material associated with the given layer. Examples ofsecondary structural materials may include seed layer materials,adhesion layer materials, barrier layer materials (e.g. diffusionbarrier material), and the like. These secondary structural materialsare typically applied to form coatings having thicknesses less than 2microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings maybe applied in a conformal or directional manner (e.g. via CVD, PVD,electroless deposition, or the like). Such coatings may be applied in ablanket manner or in a selective manner. Such coatings may be applied ina planar manner (e.g. over previously planarized layers of material) astaught in the '931 application set forth in the table below. In otherembodiments, such coatings may be applied in a non-planar manner, forexample, in openings in and over a patterned masking material that hasbeen applied to previously planarized layers of material as taught inthe '373 application set forth in the table below. These referencedapplications are incorporated herein by reference as if set forth infull herein.

“Functional structural material” as used herein is a structural materialthat would have been removed as a sacrificial material but for itsactual or effective encapsulation by other structural materials.Effective encapsulation refers, for example, to the inability of anetchant to attack the functional structural material due toinaccessibility that results from a very small area of exposure and/ordue to an elongated or tortuous exposure path. For example, large(10,000 μm2) but thin (e.g. less than 0.5 microns) regions ofsacrificial copper sandwiched between deposits of nickel may defineregions of functional structural material depending on ability of arelease etchant to remove the sandwiched copper.

“Sacrificial material” is material that forms part of a build layer butis not a structural material. Sacrificial material on a given buildlayer is separated from structural material on that build layer afterformation of that build layer is completed and more generally is removedfrom a plurality of layers after completion of the formation of theplurality of layers during a “release” process that removes the bulk ofthe sacrificial material or materials. In general sacrificial materialis located on a build layer during the formation of one, two, or moresubsequent build layers and is thereafter removed in a manner that doesnot lead to a planarized surface. Materials that are applied primarilyfor masking purposes, i.e. to allow subsequent selective deposition oretching of a material, e.g. photoresist that is used in forming a buildlayer but does not form part of the build layer) or that exist as partof a build for less than one or two complete build layer formationcycles are not considered sacrificial materials as the term is usedherein but instead shall be referred as masking materials or astemporary materials. These separation processes are sometimes referredto as a release process and may or may not involve the separation ofstructural material from a build substrate. In many embodiments,sacrificial material within a given build layer is not removed until allbuild layers making up the three-dimensional structure have been formed.Of course sacrificial material may be, and typically is, removed fromabove the upper level of a current build layer during planarizationoperations during the formation of the current build layer. Sacrificialmaterial is typically removed via a chemical etching operation but insome embodiments may be removed via a melting operation orelectrochemical etching operation. In typical structures, the removal ofthe sacrificial material (i.e. release of the structural material fromthe sacrificial material) does not result in planarized surfaces butinstead results in surfaces that are dictated by the boundaries ofstructural materials located on each build layer. Sacrificial materialsare typically distinct from structural materials by having differentproperties there from (e.g. chemical etchability, hardness, meltingpoint, etc.) but in some cases, as noted previously, what would havebeen a sacrificial material may become a structural material by itsactual or effective encapsulation by other structural materials.Similarly, structural materials may be used to form sacrificialstructures that are separated from a desired structure during a releaseprocess via the sacrificial structures being only attached tosacrificial material or potentially by dissolution of the sacrificialstructures themselves using a process that is insufficient to reachstructural material that is intended to form part of a desiredstructure. It should be understood that in some embodiments, smallamounts of structural material may be removed, after or during releaseof sacrificial material. Such small amounts of structural material mayhave been inadvertently formed due to imperfections in the fabricationprocess or may result from the proper application of the process but mayresult in features that are less than optimal (e.g. layers with stairssteps in regions where smooth sloped surfaces are desired. In such casesthe volume of structural material removed is typically minusculecompared to the amount that is retained and thus such removal is ignoredwhen labeling materials as sacrificial or structural. Sacrificialmaterials are typically removed by a dissolution process, or the like,that destroys the geometric configuration of the sacrificial material asit existed on the build layers. In many embodiments, the sacrificialmaterial is a conductive material such as a metal. As will be discussedhereafter, masking materials though typically sacrificial in nature arenot termed sacrificial materials herein unless they meet the requireddefinition of sacrificial material.

“Supplemental sacrificial material” as used herein refers to a materialthat does not form part of the structure when the structure is put touse and is not added as part of the build layers but instead is added toa plurality of layers simultaneously (e.g. via one or more coatingoperations that applies the material, selectively or in a blanketfashion, to a one or more surfaces of a desired build structure that hasbeen released from an initial sacrificial material. This supplementalsacrificial material will remain in place for a period of time and/orduring the performance of certain post layer formation operations, e.g.to protect the structure that was released from a primary sacrificialmaterial, but will be removed prior to putting the structure to use.

“Primary sacrificial material” as used herein is a sacrificial materialthat is located on a given build layer and which is typically depositedor applied during the formation of that build layer and which makes upmore than 20% of the sacrificial material volume of the given buildlayer. In some embodiments, the primary sacrificial material may be thesame on each of a plurality of build layers or may be different ondifferent build layers. In some embodiments, a given primary sacrificialmaterial may be formed from two or more materials by the alloying ordiffusion of two or more materials to form a single material.

“Secondary sacrificial material” as used herein is a sacrificialmaterial that is located on a given build layer and is typicallydeposited or applied during the formation of the build layer but is nota primary sacrificial materials as it individually accounts for only asmall volume of the sacrificial material associated with the givenlayer. A secondary sacrificial material will account for less than 20%of the volume of the sacrificial material associated with the givenlayer. In some preferred embodiments, each secondary sacrificialmaterial may account for less than 10%, 5%, or even 2% of the volume ofthe sacrificial material associated with the given layer. Examples ofsecondary structural materials may include seed layer materials,adhesion layer materials, barrier layer materials (e.g. diffusionbarrier material), and the like. These secondary sacrificial materialsare typically applied to form coatings having thicknesses less than 2microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings maybe applied in a conformal or directional manner (e.g. via CVD, PVD,electroless deposition, or the like). Such coatings may be applied in ablanket manner or in a selective manner. Such coatings may be applied ina planar manner (e.g. over previously planarized layers of material) astaught in the '931 application set forth in the table below. In otherembodiments, such coatings may be applied in a non-planar manner, forexample, in openings in and over a patterned masking material that hasbeen applied to previously planarized layers of material as taught inthe '383 application set forth in the table below. These referencedapplications are incorporated herein by reference as if set forth infull herein.

“Adhesion layer”, “seed layer”, “barrier layer”, and the like refer tocoatings of material that are thin in comparison to the layer thicknessand thus generally form secondary structural material portions orsacrificial material portions of some layers. Such coatings may beapplied uniformly over a previously formed build layer, they may beapplied over a portion of a previously formed build layer and overpatterned structural or sacrificial material existing on a current (i.e.partially formed) build layer so that a non-planar seed layer results,or they may be selectively applied to only certain locations on apreviously formed build layer. In the event such coatings arenon-selectively applied, selected portions may be removed (1) prior todepositing either a sacrificial material or structural material as partof a current layer or (2) prior to beginning formation of the next layeror they may remain in place through the layer build up process and thenetched away after formation of a plurality of build layers.

“Masking material” is a material that may be used as a tool in theprocess of forming a build layer but does not form part of that buildlayer. Masking material is typically a photopolymer or photoresistmaterial or other material that may be readily patterned. Maskingmaterial is typically a dielectric. Masking material, though typicallysacrificial in nature, is not a sacrificial material as the term is usedherein. Masking material is typically applied to a surface during theformation of a build layer for the purpose of allowing selectivedeposition, etching, or other treatment and is removed either during theprocess of forming that build layer or immediately after the formationof that build layer.

“Multilayer structures” are structures formed from multiple build layersof deposited or applied materials.

“Multilayer three-dimensional (or 3D or 3-D) structures” are MultilayerStructures that meet at least one of two criteria: (1) the structuralmaterial portion of at least two layers of which one has structuralmaterial portions that do not overlap structural material portions ofthe other.

“Complex multilayer three-dimensional (or 3D or 3-D) structures” aremultilayer three-dimensional structures formed from at least threelayers where a line may be defined that hypothetically extendsvertically through at least some portion of the build layers of thestructure will extend from structural material through sacrificialmaterial and back through structural material or will extend fromsacrificial material through structural material and back throughsacrificial material (these might be termed vertically complexmultilayer three-dimensional structures). Alternatively, complexmultilayer three-dimensional structures may be defined as multilayerthree-dimensional structures formed from at least two layers where aline may be defined that hypothetically extends horizontally through atleast some portion of a build layer of the structure that will extendfrom structural material through sacrificial material and back throughstructural material or will extend from sacrificial material throughstructural material and back through sacrificial material (these mightbe termed horizontally complex multilayer three-dimensional structures).Worded another way, in complex multilayer three-dimensional structures,a vertically or horizontally extending hypothetical line will extendfrom one or structural material or void (when the sacrificial materialis removed) to the other of void or structural material and then back tostructural material or void as the line is traversed along at least aportion of the line.

“Moderately complex multilayer three-dimensional (or 3D or 3-D)structures” are complex multilayer 3D structures for which thealternating of void and structure or structure and void not only existsalong one of a vertically or horizontally extending line but along linesextending both vertically and horizontally.

“Highly complex multilayer (or 3D or 3-D) structures” are complexmultilayer 3D structures for which the structure-to-void-to-structure orvoid-to-structure-to-void alternating occurs once along the line butoccurs a plurality of times along a definable horizontally or verticallyextending line.

“Up-facing feature” is an element dictated by the cross-sectional datafor a given build layer “n” and a next build layer “n+1” that is to beformed from a given material that exists on the build layer “n” but doesnot exist on the immediately succeeding build layer “n+1”. Forconvenience the term “up-facing feature” will apply to such featuresregardless of the build orientation.

“Down-facing feature” is an element dictated by the cross-sectional datafor a given build layer “n” and a preceding build layer “n−1” that is tobe formed from a given material that exists on build layer “n” but doesnot exist on the immediately preceding build layer “n−1”. As withup-facing features, the term “down-facing feature” shall apply to suchfeatures regardless of the actual build orientation.

“Continuing region” is the portion of a given build layer “n” that isdictated by the cross-sectional data for the given build layer “n”, anext build layer “n+1” and a preceding build layer “n−1” that is neitherup-facing nor down-facing for the build layer “n”.

“Minimum feature size” refers to a necessary or desirable spacingbetween structural material elements on a given layer that are to remaindistinct in the final device configuration. If the minimum feature sizeis not maintained on a given layer, the fabrication process may resultin structural material inadvertently bridging the two structuralelements due to masking material failure or failure to appropriatelyfill voids with sacrificial material during formation of the given layersuch that during formation of a subsequent layer structural materialinadvertently fills the void. More care during fabrication can lead to areduction in minimum feature size or a willingness to accept greaterlosses in productivity can result in a decrease in the minimum featuresize. However, during fabrication for a given set of process parameters,inspection diligence, and yield (successful level of production) aminimum design feature size is set in one way or another. The abovedescribed minimum feature size may more appropriately be termed minimumfeature size of sacrificial material regions. Conversely a minimumfeature size for structure material regions (minimum width or length ofstructural material elements) may be specified. Depending on thefabrication method and order of deposition of structural material andsacrificial material, the two types of minimum feature sizes may bedifferent. In practice, for example, using electrochemical fabricationmethods and described herein, the minimum features size on a given layermay be roughly set to a value that approximates the layer thickness usedto form the layer and it may be considered the same for both structuraland sacrificial material widths and lengths. In some more rigorouslyimplemented processes, examination regiments, and rework requirements,it may be set to an amount that is 80%, 50%, or even 30% of the layerthickness. Other values or methods of setting minimum feature sizes maybe set.

“Sublayer” as used herein refers to a portion of a build layer thattypically includes the full lateral extents of that build layer but onlya portion of its height. A sublayer is usually a vertical portion ofbuild layer that undergoes independent processing compared to anothersublayer of that build layer.

Tissue Shredding Devices, Methods for Making and Methods for Using

FIGS. 5-7 illustrate an exemplary embodiment of a working end of atissue removal device which can be fabricated wholly or in part byelectrochemical fabrication techniques, such as those described orreferenced herein. Tissue removal device working end 100 has a distalregion “D” and proximal region “P,” and includes housing 101 and bladestacks 102 and 104. Blade stacks 102 and 104 include a plurality ofblades 102A-102C and 104A-104C, respectively. Three blades are shown ineach stack, although the blade stacks can have one or more blades. Eachof the blades includes a plurality of teeth 106 (see FIG. 7), some ofwhich are shown projecting from housing 101 and configured to engage andprocess tissue. Processing tissue as used herein includes any of cuttingtissue, shredding tissue, capturing tissue, any other manipulation oftissue as described herein, or any combination thereof. The working endof the device generally has a length L, height H, and width W. Housing101 can have a variety of shapes or configurations, including agenerally cylindrical shape.

In this embodiment both blade stacks are configured to rotate. Theblades in blade stack 102 are configured to rotate in a directionopposite that of the blades in blade stack 104, as designated by thecounterclockwise “CCW” and clockwise “CW” directions in FIG. 5. Theoppositely rotating blades direct material, such as tissue, into aninterior region of housing 101 (described in more detail below). In someembodiments, the blades can be made to rotated in directions opposite tothose indicated, e.g. to disengage from tissue if a jam occurs or tocause the device to be pulled distally into a body of tissue when givenappropriate back side teeth configurations.

Housing 101 also includes a drive mechanism coupler 105, shown as asquare hole or bore, which couples a drive train disposed in the housingto a drive mechanism disposed external to the housing. The drivemechanism, described in more detail below, drives the rotation of thedrive train, which drives the rotation of the blades. The drive traindisposed in the housing can also be considered part of the drivemechanism when viewed from the perspective of the blades. Drivemechanism coupler 105 translates a rotational force applied to thecoupler by the drive mechanism (not shown) to the drive train disposedwithin housing 101.

FIG. 5 also shows release holes 111-115 which allow for removal ofsacrificed material during formation of the working end.

FIG. 6 shows a perspective view of the proximal end of tissue removaldevice working end 100. Material directed into housing 101 by therotating blades is directed into chamber 103, wherein it can be storedtemporarily or directed further proximally, as described below. A firstgear train cover 121 provides for a first surface of chamber 103, whilea second gear train cover 122 provides a second surface of chamber 103.FIG. 6 also shows drive mechanism coupler cover 123.

In some embodiments in which the working end 100 includes a storagechamber, the chamber may remain open while in other embodiments it maybe closed while in still other embodiments it may include a filter thatonly allows passage of items of a sufficiently small size to exit.

FIG. 7 shows a perspective view of the distal end of the working end100. In this embodiment the blades in stack 102 are interdigitated withthe blades in stack 104 (i.e. the blade ends are offset vertically alongdimension H and over have maximum radial extensions that overlaplaterally along the width dimension W. The blades can be formed to beinterdigitated by, e.g. if formed using a multi-layer, multi-materialelectrochemical fabrication technique, forming each blade in stack 102in a different layer than each blade in stack 104. If during formationportions of separately moveable blade components overlap laterally theoverlapping blade must not just be formed on different layers but formedsuch an intermediate layer defined a vertical gap between them. Forexample, the bottom blade in stack 102 is shown formed in a layerbeneath the layer in which the bottom blade in stack 104 is formed.

FIG. 8 illustrates a perspective view of an exemplary gear train systemwhich can be included in any suitable working end described herein todrive the rotation of the blades (such as the embodiment of the workingend shown in FIGS. 5-7). The gear train system includes drive mechanismcoupler 105 at a first end of the gear train which is coupled to gear131A in first gear train 131, and is coupled to gear 141A in gear train141. Coupler 105, in response to a rotational force applied via arotating pin (not shown) which may be considered part of the drivemechanism or a separate component of the device, drives the gears infirst gear train 131 and the gears in the second gear train 141, whichdrives the respectively coupled blade stacks to rotate in oppositedirections. Gears 131D and 141E are coupled to blade stack shafts, whichallow the gear trains to drive the rotation of the blades. Gear trains131 and 141 include gears 131A-131D and 141A-141E, respectively. Byhaving an odd number of gears in one gear train and an even number ofgears in the other gear train, the blades will rotate in oppositedirections. The arrows in FIG. 8 show the direction of forward rotationof the gears and the blades.

A potential challenge when fabricating parts or components of a deviceusing a multi-layer multi-material electrochemical fabrication processor other similar process can be creating very small gaps, or spaces,between components of the device. Potential challenges are describedabove in the “Minimum feature size” definition section. In someembodiments the gears are formed using an electrochemical fabricationprocess or other similar process and are formed in a singlemulti-material layer. One challenge in forming micro-gears in thismanner can be making sure the gaps between teeth on adjacent gears (i.e.meshing gears) can be formed consistently and with appropriatedimensions. For example, FIG. 9 shows a portion of two adjacent gears G1and G2 formed from a multi-layer, multi-material electrochemicalfabrication process. The gears are formed in this configuration, suchthat at least one tooth on one of the gears is formed “in-between” twoteeth on the adjacent gear. Gear G1 includes teeth G1 a and G1 b andgear G2 includes teeth G2 a and G2 b. During the fabrication process,gaps “g,” formed between structural material depositions of the teeth ofgear G1 and gear G2 must be large enough to meet an associated minimumfeature size while still providing a desired engagement with teeth ofthe adjacent gear so that a backlash is not excessive and so thatbinding of the gears does not occur due to either lateral shifting ofgears as a result of lateral shifting of their axles within theirengagement holes or canting or tilting of the gears relative to oneanother as a result of out of movement that may be allowed by thespacing between the gear shafts and their guide holes.

FIG. 10 illustrates an exemplary embodiment of a first gearconfiguration for assembled fabrication which allows for minimizingbacklash while still meeting minimum feature size limitations in bothgear tooth spacing as well as axle shaft and guide hole, bearing orbushing spacing. Each gear is formed from more than one layer ofmaterial rather than one layer of material. Each gear “layer” may bereferred herein as a “tier.” Driving gear 161 includes upper tier 162,lower tier 165, and intermediate tier 166. Intermediate tier is formedas a separate layer and is between upper tier 162 and lower tier 165.Upper tier 162 includes tooth 164 and lower tier 165 includes tooth 163.Six teeth are shown on the upper and lower tiers, while there are noteeth on the intermediate tier. Driven gear 151 is formed in the samemanner as driving gear 161 and includes upper tier 156 including tooth153, lower tier 155 including tooth 152, and intermediate tier 154. Sixteeth are shown on the upper and lower tiers in driven gear 151, whilethere are no teeth on intermediate tier 153.

The teeth on gears 161 and 151 mesh properly and behave may behave, forexample, as an involute spur gears. In operation, tooth 164 of uppertier 162 of driving gear 161 contacts and drives tooth 153 on the uppertier 156 of driven gear 151. Tooth 163 on lower tier 165 of driving gear161 contacts and drives tooth 152 on lower tier 155 of driven gear 151.

In some embodiments, the teeth are formed such that as the gears turnthere are always two consecutive teeth on the driving gear on differenttiers (e.g., tooth 164 and tooth 163 of driving gear 161) that are incontact with two consecutive teeth on the driven gear (e.g. tooth 153and tooth 152 on driven gear 151). The gears can be fabricated such thatthe distance, or gap dimension, between consecutive teeth on a singletier is maximized, which may be beneficial if the gap size would havebeen too small for fabrication if all gear teeth were on a single tierinstead of split between different tears.

It is possible to drive the gear train in both directions. In someembodiments, additional tiers with teeth may be incorporated into thegears so that gear interfaces (i.e., contact between teeth on adjacentgears) do not occur on merely two levels but rather occur on three ormore levels.

FIGS. 11 and 12 show three gears in an “as fabricated” configuration.FIG. 11 is a top view of gear 170, gear 173, and gear 174. Gear 170includes tooth 171 and tooth 172 on its upper tier, separated bydistance, or gap, “gb.” Gear 173 includes tooth 175 and 176 on its uppertier. Teeth 175 and 176 are fabricated separated on either side of tooth172 of gear 170 by a distance, or gap, “gs.” By using a multi-tieredgear, the distance gs between the teeth on adjacent gears is larger thanif the teeth on gears 170 and 173 were on a single tier. FIG. 12 shows across-sectional perspective view of the three gears from FIG. 11,illustrating upper tier 177 and lower tier 178 which are separated by anintermediate tier 179 without teeth that may be relatively thin (e.g. ½,⅕, 1/10, or even 1/20 or less of the thickness of the upper and lowertiers). These intermediate tiers allow a lower tiered tooth on one gearto be fabricated under an upper tier tooth such that they partially orcompletely laterally (i.e. within the dimensions the layers, e.g. XYdimensions, relative to the axis of stacking of the layers, e.g. the Zdimension) overlap without causing layer-to-layer adhesion of the teethdue to the presence of an intermediate volume of sacrificial materiallocated vertically between them. Forming gears with multiple tiers,allows for intra-layer gaps between teeth of adjacent gears (i.e.engaging gears) to remain above a minimum feature size while allowingeffective gaps between engaging gears as a whole to have a much smallertooth gap or tighter tooth pitch. In some embodiments, the existence ofintermediate non-toothed tiers allows tighter teeth spacing and/or widerteeth dimensions without needing to resort to gears with more than twotoothed tiers. Multi-tier gears as set forth in the example, provide anengage method and components for forming tightly-meshed teeth whileallowing necessary gaps to be reliably formed between teeth on adjacentgears. In some embodiments, each tier may be formed from a singlemulti-material layer, while in other embodiments each tier may be formedfrom a plurality of multi-material layers.

In embodiments in which a gear has more than one tier, and it may bepossible to remove one or more of the immediate tiers (i.e. those thatdo not have gear teeth) as it may be possible to form gear teeth onmultiple levels without any two consecutive levels having teeth thatoverlap in the X-Y plane in the as formed position.

FIGS. 13 and 14 highlight the proximal end and distal end, respectively,of the gear trains shown in FIG. 8, which incorporate a multi-tieredgear design. Gear 131A is comprised of a first tier 131A1 and a secondtier 131A2, each having six teeth. Rotation of gear 131A due torotational forces on the drive mechanism coupler 105 causes the teeth ontier 131A1 to contact and drive the teeth on tier 131 B1 of gear 131B,while teeth on tier 131A2 engage teeth on tier 131B2. The gears in geartrain 141 also include multi-tiered or multi-layered gears and functionin the same way. FIG. 14 illustrates the distal end of the gear train,illustrating gear 131C comprising tier 131C1, which is configured torotate and engage with tier 131 D1 of gear 131D, and tier 131C2, whichis configured to rotate and engage with tier 131 D2 of gear 131D.Rotation of gear 131D rotates the blades in blade stack 102 about ablade shaft (not shown).

FIG. 15 illustrates an alternative embodiment of a gear formation thatcan be used in any of the tissue removal devices herein. The drive trainincludes driving gear 180, gear 184, and gear 188 formed by an EFABprocess in the configuration shown. In this embodiment the gears arecomprised of multiple tiers, but not all of the teeth alternate amongsttiers as in the embodiment in FIGS. 8-14. In this embodiment only theteeth that are near teeth on an adjacent gear in the “as-fabricated”configuration are formed in only one tier, while the remaining teeth onthe gears are formed in all tier layers. In terms of teeth height, theteeth that are near teeth on an adjacent gear during formation have ashorter height (with height being measured in the layer stackingdirection and the gears being formed with their planes lying in theplanes of the layers) than the other teeth on the gear. In reference toFIG. 15, driving gear 180 includes an upper tier and a lower tier,wherein the nine teeth 195 (only three of which are labeled) are threelayers (or tiers) thick (i.e. upper, lower, and intermediate tiers).Teeth 181, 182, and 183 are each only one layer thick, with teeth 182and 183 formed only in the lower tier, and tooth 181 is formed only inthe upper tier. Gear 184 is formed in a similar manner, with all of theteeth except for teeth 185, 186, 187, 189, 190, and 193 formed in boththe upper and lower tiers. Teeth 185, 187, 189, and 190 are formed onlyin the upper tier, and teeth 186 and 193 are formed only in the lowertier. Gear 188 is formed in the same manner as 180. In use, when drivinggear 180 is rotated (e.g., in a clockwise direction), tooth 182 contactstooth 186 on gear 184, and the first tooth 195 on gear 180 contactstooth 185 on gear 184. As gear 180 continues to rotate after almost afull revolution, lower tier tooth 183 on gear 180 contacts lower tiertooth 193 on gear 184, and upper tier tooth 181 contacts upper tiertooth 190 on gear 184.

Because teeth 195 and 196 on gears 180 and 184, respectively, are formedon multiple layers and therefore have a greater height than a toothformed on a single layer, they may be better able to make solid contactwith one another and more effectively turn the gear. It may bebeneficial to fabricate the teeth in such a manner if forming the teethon only one tier prevents the gear from turning effectively because theheight of teeth formed from a single layer of material is too small, andadequate contact is not being made between the teeth as the gearsrotate. An exemplary advantage of this design can allow for gaps to becreated that are of a large enough size while providing for bettercontact between gear teeth.

FIGS. 16-19 illustrate yet another alternative gear train design whichmay allow meeting minimum feature size requirements while providing morerobust gears along with back lash not being excessively large. FIG. 16shows driving gears 220, 221, and 222 in their as-formed configuration.Teeth 223 and 224 on gear 220, teeth 225, 226, 228 and 230 on gear 221,and teeth 227 and 229 on gear 222, are formed such that each tooth isnotched (i.e. a segment of each tooth is removed from one of the upperor lower tier and from the intermediate tier. Each of these teeth have aportion that is sacrificed to allow assembled formation of the all ofthe components (gears 220, 221, and 222) during the formation process.Sacrificing a portion of the each of these teeth allows for anintra-layer gap to be created between teeth (i.e., between teeth 223 and225, 224 and 226, 227 and 228, and 229 and 230) to be larger than theminimum feature size while allowing a tighter gear engagement with eachtooth being stronger and significantly more rigid that it was in eitherof the previous two embodiments. One method of sacrificing a portion ofthe tooth is to create each gear from three tiers (e.g. layers) ofmaterial, and forming the tooth so that the notched portion of selectedgears is formed as a single tier thickness (e.g. a single layerthickness). All of most of the teeth are three tiers thick while only asmall portion of the notched teeth are not three tiers. As noted abovetooth 223 includes portion 231, however, that is only 1 tier thick.Teeth 224, 225, 226, 227, 228, 229, and 230 also each have a portionthat is only 1 layer thick. Teeth 225, 226, 227, and 229 have portionssacrificed that cannot be seen in FIG. 16, but have positions on theteeth that allow formation of the underling teeth from the mating gearsto be formed without causing inadvertent gear bonding or welding. Bycreating a portion of a tooth that is only 1 tier thick, more intralayerspace can be created between the teeth, which can be beneficial in thefabrication process. FIG. 17 illustrates a partial perspective view ofthe three gears from FIG. 16 in their “as fabricated” configuration.

FIG. 18 shows the gears from FIGS. 16 and 17 showing the direction ofrotation as illustrated by the arrows where gear 220 is the driving gearand gears 221 and 222 are being driven. FIG. 18 also shows contactspoints 240 between the teeth. FIG. 19 shows a magnified view of contactpoints 240 between the driving and driven teeth. As shown, the portionof the tooth that is sacrificed is preferably on edge of the gear thatis opposite the side of the gears that do the driving or are beingdriven during the forward or high torque operation of the gear train.

The gear trains described above allow a drive mechanism, examples ofwhich are described above and below, to be at a distance from the bladessuch that the distal end of the working end can be advanced into contactwith tissue in an unobstructed manner.

In some alternative embodiments the all or portions of the gear train(s)can be replaced with one or more sprockets and one or more chains todrive the blades, one or more pulley and belts, one or more fluid flowpaths and turbine blades, or the like.

When manufacturing tissue removal devices of the various embodiments setforth herein using a multi-layer multi-material electrochemicalfabrication process, it is generally beneficial if not necessary tomaintain horizontal spacing of component features and widths ofcomponent dimensions remain above the minimum feature size. It isimportant that vertical gaps of appropriate size be formed betweenseparately movable components that overlap in X-Y space (assuming thelayers during formation are being stacked along the Z axis) so that theydo not inadvertently bond together and to ensure that adequate pathwaysare provided to allow etching of sacrificial material to occur. Forexample, it is generally important that gaps exist between a gearelement (e.g. a tooth) in a first gear tier and a second gear tier sothat the overlapping teeth of adjacent gears do not bond together. It isalso generally important to form gaps between components that moverelative to one another (e.g., gears and gear covers 121 and 122 (seeFIG. 20), between blades and housing 101, etc.). In some embodiments thegaps formed between moving layers is between about 2 um and about 8 um.

FIG. 20 illustrates a partial view of the working end of tissue removaldevice in which the top portion and one side wall of housing 101 havebeen removed to show one of the exemplary gear trains from FIG. 8disposed in housing 101. Gear enclosure or cover 121 encloses the firstgear train 141 (not shown) and provides a lower surface, in combinationwith the inside of housing 101, for chamber 103. FIG. 21 shows aperspective cross-sectional view of the device of FIG. 20, includingsecond gear train cover 122 wherein the cross-sectional cut sectionsgears 131B and 141C each in their as fabricated positions wherein gapsformed from sacrificial material laterally located on intervening layersexist between upper and lower surfaces of these gears and thecorresponding lower surfaces of covers 122 and 121 and upper surfaces ofthe lower portions of housing 101. The gear train covers 121 and 122extend from the proximal end of the device to a point just proximal tothe blades, and have distal ends which are rounded to accommodate therotation of the blades while preventing as much tissue as possible fromentering the gear train assembly. An exemplary function of gear covers121 and 122 is to prevent material which is directed into chamber 103from getting caught in the gears and preventing continued rotation ofthe blades. FIG. 21 also illustrates the section of gear 141-C exposesshaft 142-C around which gear 141-C rotates via a circular gaps (e.g.having an intralayer radial width greater than the minimum featuresize). Also FIG. 21 illustrates that when gears 131B and 141C are intheir as formed positions, they have etching holes 112-B and 114-Brespectively that are aligned with etching holes 112-A and 114-A inhousing 101 that allow more direct entry of etchant into the gearmovement cavities defined by covers 122 and 121 in conjunction withhousing 101 so that post-layer formation etching of sacrificial materialcan more readily occur from these cavities. In some embodiments partialalignment would be better than no alignment and offset of etching holesby no more than 2 mm or even 5 mm would be beneficial as compared tooffsets which are significantly greater. FIG. 21 also shows a portion ofblade shaft 103 around which blade stack 104 rotates. FIG. 21 along withFIG. 5 also shows interdigitated fingers 107 which are located betweensuccessive blade levels to inhibit the outflow of tissue drawing intocavity 103 as the blades tips rotate out of and then back into thehousing. Such fingers, vacuum (i.e. suction applied to the proximal endof the working end), irrigation directed onto the blades within thehousing (e.g. vertically downward or downward and proximally), or acombination of two or more of these elements may be useful in removingtissue from the blade and inhibiting its distal exit from the workingend back into working area within the body of a patient. In someembodiments, it is desired to define a shearing thickness as the gapbetween elements has they move past one another. Such gaps may bedefined by layer thickness increments or multiple such increment or bythe intralayer spacing of elements as they move past one another. Insome embodiments, shearing thickness of blades passing blades or bladesmoving past interdigitated fingers, or the like may be optimally set inthe range of 2-100 microns or some other amount depending on theviscosity or other parameters of the materials being encounter and whatthe interaction is to be (e.g. tearing, shredding, transporting, or thelike). For example for shredding or tearing the gap may be in the rangeof 2-10 microns and more preferably in the range of 4-6 microns.

As described in the embodiments above, the working end includes a drivemechanism coupler 105 that is configured to be coupled to a drivemechanism which translates a rotational force to rotation of the firstset of gears in each of the gear trains. For example, as shown in FIG.5, drive mechanism coupler 105 has a square configuration and is adaptedto receive a square drive pin (not shown), wherein the pin is part of adrive mechanism which translates a rotational force to rotation of thegears in the train. FIG. 22 illustrates an alternative drive mechanismcoupler 250 with a D-shaped hole, or bore, 251, which is adapted toreceive D-shaped element 253 which can be engaged with a chain, a belt,a fluid flow, an electrical motor, a flexible drive shaft, bevel gear,crown gear, a spur gear, linear gear, or the like which can undergo amotive force to cause a desired rotation of the drive chain and bladesto power the device. The shaped element may be part of a pin or otherelement which allows appropriate engagement. The cross sectional shapeof the drive bore and pin can also be almost any other cross-sectionalshape which can drive the gear train, for example, a hexagonal shape,oval, elliptical, etc.

FIGS. 23A-27C illustrate alternative exemplary embodiments of drivemechanisms which can power the drive trains in the working end, any ofwhich may be adapted to be included in any suitable tissue removaldevice, such as those described herein. To position the working end at adesired location in the patient, the working end can be advanced to thetarget site within a delivery member (e.g., cannula, catheter, sheath,etc.). A portion of the device, e.g. the working end or the working endin combination with a single or multi-port catheter can also be adaptedto be advanced over a guide wire. In some embodiments, the tissueremoval device is coupled to an elongate introducer which is used toadvance the working end of the tissue removal device to the targettissue site through a delivery member. In some embodiments, the drivemechanism, or at least a portion thereof, is disposed within theintroducer. An example delivery systems are described in more detailbelow.

FIGS. 23A-23D illustrate a first embodiment of the working end and drivesystem of a device in which the drive mechanism includes a belt andpulley. FIG. 23A shows a portion of housing 270, tissue processingelements 271, a portion of gear train 276, belt 272, and pulley 273.FIG. 23B shows a sectional view including belt 272 and a portion ofpulley 273 disposed in housing 270. FIG. 23C shows the housing 270without the belt. FIG. 23D shows a sectional view of housing 270including a portion of pulley 273, drive mechanism coupler 275, andoptional guide wire lumen 274 disposed on the bottom of housing 270.Actuating the belt as shown by the arrows in FIGS. 23A and 23B causespulley 273 to rotate due to frictional forces between the belt andpulley. The pulley includes a protruding pin (not shown) which coupleswith drive mechanism coupler 275 to drive the gear train. Rotation ofthe pulley 273 drives the gear trains which activates the tissueprocessing elements 271. In some embodiments the belt is a nitinol wirebut can be any other suitable material. In other embodiments, the smoothbelt and pulley may be replaced with a chain and sprocket or with aminiature toothed pulley and toothed belt. In some embodiments, thepulley and belt be controlled, at times, to drive the tissue processingelements in the opposite direction to that indicated.

FIGS. 24A-C illustrate a second embodiment of the working end and drivesystem of a device in which the drive mechanism is a hydraulic drivemechanism. FIG. 24A shows a portion of the device including a portion ofhousing 280, tissue processing elements 283, turbine 281 with aplurality of blades 287 coupled to a driving pin (not shown in FIG.24A), wherein turbine 281 is coupled to drive mechanism coupler 282 viathe pin. FIG. 24B is a sectional view of housing 280 in which turbine281 is disposed. Housing 280 includes fluid channel 288 through whichfluid (e.g., liquid or gas) flows in the direction of arrow 284,rotating turbine 281. The fluid exits the housing in the direction ofarrow 285 through fluid channel 289. The fluid rotates the blades 287 ofturbine 281, which drives the gear train, which activates the tissueprocessing elements 283. A pump disposed proximal to the housing (e.g.outside the body of the patient and connected to the working end bylumens within a multi-port catheter) and can be used to control the flowof fluid into the housing. In some embodiments, the pump and otherelements in the fluid flow path may be configured to allow reversedoperation of the device when desired.

In the embodiments above the tissue removal, or processing, elements andthe housing of the working end are configured such that the tissueremoval elements can remove tissue which is located distal to theworking end. The tissue removal elements can also be, however, disposedat other locations within the working end. In some embodiments they aredisposed so that they can remove tissue along one or more sides of thehousing. In some uses the device may be advanced in a distal direction,yet the tissue which is to be removed is located along the sides of thedevice. As will be described in more detail below, it may beadvantageous to protect certain tissue from being damaged while removingother tissue. Positioning the blades in the working end in specificlocations can be one way to do this.

FIGS. 25A-25G illustrate an example a of a side tissue removal workingend. FIG. 25A is a top sectional view with a top portion of the housingremoved, which shows working end 290 comprising housing 298 and fourtissue removal elements 294-297, which are shown as blade stacks. Bladestacks 294 and 295 process tissue along one side of the housing bydirecting tissue in the direction of arrow 292. Blade stacks 296 and 297process tissue along a second side of the housing by directing tissue inthe direction of arrow 293. As shown in FIGS. 25A-B, blade stacks 294and 297 each have two blades, while blade stacks 295 and 296 each havethree blades. FIG. 25C shows a perspective view without housing 298illustrating the drive mechanism for the side tissue removal device 290.The drive mechanism includes belt 299, distal pulley 300, and sidepulleys 301-304. The side pulleys are coupled to the blade stacks androtation of the side pulleys rotates the blade stacks. The belt isdisposed through side pulleys 301 and 302 and around distal pulley 300before returning through side pulleys 303 and 304. Actuating of belt 299therefore activates all four blade stacks. In some embodiments the beltis a nitinol wire, but can be any other suitable material. FIG. 25D is aview with the top portion of the housing removed to show the internaldrive mechanism. FIG. 25E shows the same view with the top on thehousing. FIGS. 25F and 25G show top views of the working end shown inFIGS. 25D and 25E, respectively. In still embodiment, as well as in theother embodiments, set forth herein, vacuum, irrigation, or acombination of the two may be used to send extracted tissue from theinterior of the working end, proximally to a storage reservoir (e.g.within the working end or located outside the body of the patient onwhich a procedure is being performed).

FIGS. 26A-26F illustrate an alternative hydraulic or pneumatic drivemechanism for a side tissue removal working end. FIG. 26A shows thedevice 310 including housing 311 and tissue removal elements on a firstside 312 of device 310. FIG. 26B illustrates housing 311 with a topportion removed to reveal inside the housing. The housing includes fluidchannels which allows fluid to flow into the housing in the direction ofarrows 313 and 314. The fluid turns the blades of turbines 316 and 318,which rotates the turbines shafts, which are coupled to the tissueremoval elements. Guides 315 helps direct the flow of fluid to ensurethe blades of the turbines rotate in the proper direction to cause thetissue removal elements to rotate inward. The fluid continues past theturbines and drops through opening 320. The fluid exits through hole 321(see FIG. 26E) and out of housing in the direction of arrow 319. Theexiting fluid can also help direct tissue in the proximal direction awayfrom the working end. FIG. 26C shows a top view of the device shown inFIG. 26B. FIG. 26D shows the turbines each coupled to one blade stack.FIG. 26E is a sectional perspective view, showing fluid inlet 313,blades 317 of the turbine and a portion of the tissue removal elements.FIG. 26F shows a side sectional view of the view shown in FIG. 26E,including blade shaft 322.

FIGS. 27A-27C illustrate an alternative drive mechanism. FIG. 27Aillustrates tissue removal device 300 including working end 301 andintroducer 302. Working end 301 includes distally facing tissue shredderelements 303. FIGS. 27B and 27C illustrate the drive mechanism with asectional perspective view and a partial top view. The drive mechanismincludes tube 304 (disposed within introducer 302) with gear teeth 305cut circumferentially, which can be seen more clearly in FIG. 27C. Whenrotated, the teeth 305 on tube 304 contact and drive teeth 307 on gear306, the axis of rotation of which is substantially orthogonal to theaxis of rotation of tube 304. Pin 308 (shown with a square crosssectional shape) is engaged with a square hole in gear 306 and with asquare hole in drive mechanism coupler 312 in the working end. Rotationof gear 306 therefore rotates pin 308, which rotates the drive mechanismcoupler 312, which drives the gear trains (which can be partially seenin FIG. 12) within the working end. FIG. 27C also shows an exemplarycoupling 311 between a distal end of introducer 302 and housing 310 ofworking end 301.

The tissue removal device as shown in FIGS. 27A-C can also provideirrigation to the working end to provide for maximum suction by avacuum, which is used to remove tissue from the working end. Irrigationfluid can be delivered between inner tube 304 and the inner diameter ofintroducer tube 302. The irrigation as well as debris is then pulledproximally by suction through the lumen of inner tube 304 in thedirection of the arrow shown in the figure. Irrigating helps maximizethe suction by ensuring that the volume on the inner tube 304 is full ofboth tissue and irrigating fluid. The irrigating fluid forced distallybetween the introducer and inner tube 304 can also be directed into theworking end to provide irrigation to the working end.

In variations of the above noted embodiments the drive mechanism can beconfigured to include one or more sprockets and one or more chains.

In some alternative embodiments the drive mechanism which extendsthrough an introducer may extend a significant distant from the drivemechanism coupler (e.g. perpendicular to the plane of the upper or lowerfaces of the housing, i.e. in the Z-direction or vertical directionrelative to the planes of the layers (e.g. horizontal planes) used informing the device via multi-layer, multi-material electrochemicalfabrication methods. In other alternative embodiments the drivemechanism may be coupled to a secondary shaft or flexible lead whichextends in a direction parallel to the planes of the faces of thehousing (e.g. proximally along the longitudinal axis of the device orradially relative to the longitudinal axis of the device).

In some embodiments the drive mechanism includes universal joints, crowngears, or bevel gears coupled to drive gears and oriented so the drivetrain axis may be rotated to become parallel to the longitudinal axis ofthe device, or to otherwise lie perpendicular to the height of thedevice. In some embodiments some gears in a gear train may be formed inthe same orientation as other gears in the train, but then rotated onbendable supports or pivotable supports to take on a desiredorientation.

The working ends of the tissue removal devices described herein can beused to remove tissue from a subject. The tissue to be removed isgenerally referred to herein as “target tissue”, and the generallocation at which the working end is positioned to remove the targettissue is generally referred to herein as the target tissue “site.” Theworking end can be configured for use in a variety of types of medicalprocedures. For example without limitation, the working end can beconfigured for use in traditional open surgical procedures or minimallyinvasive procedures (i.e., any procedure less invasive than opensurgery, such as percutaneous procedures).

When the working end is used in some minimally invasive procedures, itis coupled to an elongate member of a delivery system so that theworking end can be positioned at the target tissue site. FIG. 28illustrates an exemplary coupling 322 between introducer 321 and workingend 320, wherein the introducer is adapted to introduce, or position,the working end at the target tissue site. As shown, introducer 321 iscoupled to the proximal end of the working end 320, but the introducerneed not necessarily be coupled to the proximal end of the working end320, but can be coupled to a general proximal region of working end 320.In some embodiments the coupling between introducer 321 and working end320 is performed after the fabrication of working end 320, or afterpartial fabrication of working 320. Coupling 322 can take on a varietyof forms, such as, without limitation, a lap joint, as is the exemplarycoupling 311 shown in FIG. 27C. Introducer 321 can have one or morelumens 323 (only one shown) which are in communication with the chamberwithin the working end (not shown). The lumen(s) of the introducer canhouse any or all of the drive mechanism components, irrigation system,aspiration system, etc. As shown in FIG. 28, the proximal end 325 ofhousing 326 and the distal end of introducer 321 have substantiallysimilar cross-sectional shapes (shown as generally circular), which maymake it easier to couple the working end to an introducer. Theintroducer generally extends proximally from the working end and mayhave a proximal end adapted to be disposed external to the subject. Insome embodiments the introducer is a stiff rigid element, while in someembodiments it is a torsionally stiff and flexible element. FIG. 29illustrates an exemplary articulatable introducer 330 includingnon-articulating portion 331 and articulating portion 332, wherein theintroducer is coupled to working end 333. The entire introducer may alsobe articulatable, or there may be alternating portions of articulatableand non-articulatable portions of the introducer. For some procedures itmay be known where the introducer is likely to need to bend orarticulate, and only this portion of the introducer may be configured toarticulate. The articulating segments can be articulated with deliverysystem actuators as described below.

Depending on the medical procedure, the introducer can be coupled to theworking end to advance the working end to the target tissue site througha delivery member such as, without limitation, a cannula, trocar,catheter, sheath, etc. FIG. 30 shows introducer 336 and working end 337,including shredders 338, coupled together, with a portion of introducerdisposed within delivery member 335. The introducer/working end assemblycan be moved axially relative to the delivery member by distallyadvancing the introducer and/or proximally withdrawing the deliverymember.

The working end of the device may be adapted with a lumen or bore toincorporate additional delivery system components that can be movedaxially relative to the fixed shredders within the working end. FIG. 31Aillustrates a portion of housing 339 of the working end, including fixedtissue removal elements 340, optional irrigation port 342, and slidableelement 341 disposed within a bore in housing 339. The slidable element341 can be actuated axially (i.e., distally or proximally) as shown bythe directions of the arrows using an actuator in the deliveryhand-piece or other mechanism that allows for user control. In someembodiments the introducer can have a separate lumen for the slidableelement which is aligned with the slidable element bore or lumen in theworking end.

In some embodiments the working end housing is configured with more thanone bore (the introducer can similarly have one or more lumens) toenable it to receive more than one axially movable element, which canenable more delivery tools to access the target tissue site morequickly. In some embodiments the slidable, or axially movable, elements,can be visualization tools such as a camera or an illumination tool.Focus on the target tissue can be maintained before and during theprocedure by being able to move visualization tools in this manner. Insome embodiments irrigation and/or suction tools are slidable elements.In use, a slidable element may also be configured to be retractedcompletely from the introducer/working end assembly to allow for adifferent element to be advanced to the distal end of the housing.

FIG. 31B shows an exemplary embodiment of working end 600 that isadapted to be actuated to rotate working end 600 relative to introducer602. Working end 600 pivots through drive pin 601, and actuation wires603 are coupled to working end 600 at attachment points 604. Actuationof wires 603 causes rotation of working end 600 relative to introducer602.

FIGS. 32A-32C illustrate a device and methods for providing a space forvisualization of the target site, and/or target tissue. Creating a spacein front of the tissue removal elements allows for visualization of theworking area during and after tissue removal. FIG. 32A illustrates afirst embodiment in which working end 350 includes retractable shredders351. Inflated balloon 352 is inflated in the direction of tissue that isto be removed to create a space for visualization. In one embodiment theinflatable balloon is disposed at the distal end of an axially slidableelement which is advanced to the working area through the working end ofthe device. An inflation fluid (e.g., gas, liquid) is then pumpedthrough the lumen of the slidable element into the balloon to expand theballoon. The working end also includes an optical device 353 (e.g., acamera) which can be a separate slidable element, which is distallyadvanced towards the working area to visualize the working area. Theballoon can then be deflated and retracted back into the working end.The camera is similarly retracted into the working end. The tissueremoval elements can be retractable to avoid puncturing the balloon withthe tissue removal elements.

FIG. 32B illustrates an alternative embodiment in which working end 354includes irrigation port 355, suction port 356, and camera 358. Fluid357 can be flooded into the working area in front of tissue shredders359 to provide for visualization of the working area with camera 358.The fluid can be aspirated from the working area through suction port356.

FIG. 32C illustrates an alternative embodiment in which working end 360includes an axially slidable element 361 which includes a taperedoptical cone 363 at its distal end and a camera 362 proximal to thedistal end of cone 363. The optical cone can be advanced distally infront of shredders 364 to provide a space for visualization of theworking area with camera 362. The optical cone can be retracted withinworking end 360 when not in use.

FIGS. 33A-33C illustrate an alternative arrangement of the deliverysystem for visualizing the working area. FIG. 33A illustrates workingend 371 extending from delivery member 370 (an introducer is coupled tothe working end but is within delivery member 370). In thisconfiguration the shredders can remove tissue. The introducer andworking end are then retracted proximally as shown in FIG. 33B andremoved completely from the delivery member 370 (whose proximal end ispositioned external to the patient). A separate scope 372 is thenadvanced through delivery member 370 to the working area, as shown inFIG. 33C. The scope includes camera or image bundle 373, irrigation port374, suction port 375, and illumination bundle or LED 376. In use,tissue is removed with the shredders, then the working end is removed,the scope is then advanced to visualize the working area to determinethe progress of the procedure, and the scope is then removed. Thesesteps are repeated until the desired amount of tissue has been removed.

FIG. 34, steps A-E, illustrate an exemplary procedure for treating aherniated disc by removing nucleus tissue using a tissue removal deviceas described herein. As used herein, “disc tissue” can refer to thenucleus, annulus, and endplates. The following procedure can be used toremove nucleus tissue in the cervical, thoracic, or lumbar spine. FIG.34A shows disc 370 (vertebrae not shown for clarity) including annulus371 and nucleus 372. Using an imaging technique such as fluoroscopy or aCT scan, delivery member 373 (e.g., a delivery cannula) and dilator 374,which is shown with a “bullet” tip, are advanced towards disc 370 ineither a posterior or anterior approach. Dilator 374 and delivery member373 are then advanced through the annulus, as shown in FIG. 34B. Thedilator's bullet tip shape separates and expands the fibers of theannulus and does not cut or tear them. Once the distal end of deliverymember 373 is positioned at the desired location, dilator 374 iscompletely withdrawn from delivery member 373, as shown in FIG. 34C.Tissue removal device 375 is then advanced through delivery member 373,positioning the working end at the target tissue site, as shown in FIG.34D. The tissue removal elements are then activated by a physician via ahandpiece portion of the delivery system (not shown) to remove disctissue to repair a herniated disc, as shown in FIG. 34E. In thisembodiment delivery member 373 protects the annulus from the tissueshredders.

In an alternative method, rather than positioning delivery member 373under fluoroscopy or CT scan, dilator 374 incorporates a visualizationtool such as a camera which can be used to position delivery device 373.

An exemplary advantage of using a tissue removal device as describedherein to remove nucleus tissue is that the tissue can be removed withminimal damage to the annulus and endplates. The tissue processingelements can be manufactured to have dimensions that allows for safe andefficient removal of nucleus tissue. Additionally, by using small tissueprocessing elements, it is less likely that endplate or annulus tissuewill be damaged or unintentionally removed from the patient.

In other procedures the tissue removal device can specifically be usedto remove annulus tissue as well. For example, in complete disc removalprocedures, the tissue removal devices herein can be used to remove theentire disc.

The tissue removal devices herein can also be used to treat spinalstenosis. The tissue removal devices herein can be used to remove bloodclots in a thrombectomy, or to remove plaque in an atherectomy. Theseare merely examples of procedures that can be performed with the tissueremoval devices herein to remove tissue from a subject, and the devicesherein can be adapted to be used in other procedures. As necessary, theycan be adapted to be coupled to additional delivery system components tobetter adapt them for certain procedures.

In embodiments in which the blades are disposed at the distal end of theworking end, the working end can be advanced distally to engage andremove tissue. It may need to be retracted and advanced several times toremove the target tissue. It may also be necessary to change thedirection in which the working end is advanced each time to ensure thattissue is continuously and efficiently removed. In embodiments in whichthe blades are disposed on a side or sides of the working end, it may benecessary to laterally move the working end in a sweeping motion toremove the tissue. The working end may also be rotated during use (e.g.via rotation of the introducer).

In use, the tissue removal device may be used in combination withexpanders and/or distal protection devices. The tissue removal devicesherein may also be used in combination with forceps or claws to pull orpush tissue toward the blades.

The tissue removal devices as described herein may include a useractuation member, such as a hand-piece or other external controlmechanism for controlling and actuating the tissue removal device. Theactuation member generally includes an actuator adapted to turn theprocessing blades on and off, such as via a motor. The same actuator ora different actuator(s) can be adapted to control an irrigation/suctionsystem, such as by activating a pump to force a fluid distally throughan irrigation tube, while activating a vacuum to apply suction to pulltissue and irrigation fluid back proximally through the introducer. Anyother actuators can be incorporated into an external control mechanismto control the operation of the working end, drive mechanism,irrigation/suction system, etc.

According to some embodiments of the disclosure the drive mechanism maybe powered by an electric motor located in proximity to the device, anelectric motor located at the end of a flexible shaft drive wherein themotor is remote from the device (e.g. outside the body when the deviceis used at the end a catheter or other delivery lumen in a minimallyinvasive procedure.

The tissue removal devices described herein are generally configured toremove target tissue from a subject. “Removing,” or the “removal” oftissue from a subject as used herein include any and all of the stepsinvolved in removing tissue at least from the target tissue area, and insome embodiments removing the tissue completely from the subject's body.The working end of the device comprises blades which initiate the tissueprocessing step. Processing tissue as used herein includes cuttingtissue, directing tissue from a location in the patient to a differentlocation, and capturing, or entraining tissue, as well as directingtissue proximally through the delivery system to a location external tothe patient. While “blades” as used herein may imply a cutting orshredding motion, the working end can includes many different types ofblades, not all of which cut, shred, or tear tissue; some may merely beinvolved in directing the tissue from one location to another (whetherfrom external to the device to a location internal to the device, orfrom a location internal to the device to a second location internal tothe device). In some cases in which a blade is described as merelydirecting tissue from one location to another, there may of course besome incidentally tearing, cutting, and/or shredding. Additionally, thetissue which is removed from the target tissue area may be stored atleast temporarily within the tissue removal device (e.g., in a tissuestorage chamber), or the tissue may immediately be directed from thetarget tissue area to a location external to the tissue removal device(e.g., through a suction lumen). In either case, the tissue can be movedwithin the tissue removal device by, for example without limitation, avacuum or other extraction mechanism such as an Archimedes screw orother mechanical conveyor.

The blades of the tissue removal devices may be configured to optimizeone or more of the above functions, and in some embodiments the bladesshape and function to be performed are influenced by the type of tissuethat is being removed.

FIG. 35 illustrates an exemplary embodiment wherein the axes of rotation384 of the rotors for blades 382 are substantially orthogonal to thelongitudinal axis 383 of at least the working end 381. As used herein,“substantially orthogonal” includes angles that are +/−about 30 degreesto the right angle. That is, angles between the two axes that are about60 degrees to about 120 degrees are considered substantially orthogonal.In some embodiments the rotors are not fixed relative to the workingend, but instead can be articulated in one or more directions. In theseembodiments the rotor axis is considered orthogonal if it can be rotated+/−about 30 degrees. In embodiments described above in which the bladesare oriented along a side of the working end, the axes of rotation ofthe blade rotors are also substantially orthogonal to the longitudinalaxis of at least the working end.

In generally, the tissue removal device includes at least one orthogonalrotor. FIG. 36 shows a distal end of a working end including a singlerotor 391 and stator 392 wherein the stator includes fingers or otherelements that work with the rotor to cause shredding or other disruptionof the tissue into small pieces that may be removed via the device fromthe body of the patient. In some embodiments the single rotor mayinclude a plurality of blade elements located in parallel with oneanother to allow wider contact with tissue to be removed.

FIG. 37 shows exemplary blade profiles, wherein profiles 400, 404, and408 would be most beneficial in removing soft tissue. Blade profiles412, 416, and 420 would be most beneficial in removing bone. Profile 400shows a blade shape for “hooking” which has a non-sharpened or dulledge. Profile 404 shows a blade for slicing, which is hooked-shaped witha sharp edge. Blade profile 408 can be used for shredding, and ishooked-shaped with serrations. The blade profiles for cutting bone aregenerally not hooked shaped and are more symmetrical. The shapes producea more robust blade for contacting hard materials. Blade profile 412 hasa sharp point and creates high pressure when cutting through corticalbone. Blade profiles 416 and 420 have a flat tip and square tip,respectively, and these blunt tips can be used for cortical bone but maybe more suited for cancellous bone.

FIG. 38 shows some additional exemplary blade types, supplementing someof the blade types shown in FIG. 37. Blades 422 a and 422 b illustrate abone grinder with a serrated tip. Blade 424A-434 d have a hooking shaftwhich can be used to remove soft tissue. The hooking shape can also havea sharp edge as shown in 424 d. Blades 426A-436C can be used to tearthrough soft tissue, and can have a barbed edge as shown in FIG. 426C.Blade 428A-428B can be used for slicing soft tissue, and can have asharp edge as shown in 428B. Blade 430A-430C can be used for scoringsoft tissue, and can have a scoring edge as shown in 430 b.

FIGS. 39A-39C illustrate exemplary embodiments of double rotor bladedesigns. FIG. 39A shows a first rotor 440A and a second rotor 442 in anoverlapping, or interdigitated, configuration, with overlapping region444. Tissue 445 is being pulled centrally inward as the two rotorsrotate in opposite directions. This is the configuration of the bladesin the blade stacks shown in, for example, FIG. 7. FIG. 39B showsnon-overlapping, or non-interdigitated, rotors 446 and 448 pullingtissue 447 into the working end of the device. The left portion of FIG.39C provides a schematic illustration of a blade element of extendedheight (e.g. numerous layers) which may be used for transportingmaterial as opposed to tearing or shredding it. While the right mostside of FIG. 39C shows how the teeth of such blades may meshed but notcontacting so as to cause transportation of intervening material asrotation occurs. On the right of FIG. 39C, rotor 449 and rotor 450 havemeshed teeth (e.g., 451 and 452) like a gear which have tall profiles asshown. Rotors 449 and 450 can effectively work like a gear pump as apressure differential is created when the rotors begin to rotate, whichcan draw high viscosity gelatinous material (e.g., nucleus material froma spinal disc, blood clots, etc.) into the working end of the device.Unlike the blade stacks 102 and 104 as shown in FIG. 7, rotors 449 and450 can be fabricated from one solid extrusion, which gives the blades ataller profile.

FIGS. 40A (perspective view) and 40B (top view) illustrate analternative embodiment of working end 500 in which tissue is capturedand processed in multiple steps. The rotating elements at the mostdistal end (rotor 504) are not sharp and merely pull tissue into thehousing, while secondary blades (503 and 502) process the capturedtissue into smaller segments. Driving gear (left gear) and blade 502 isshown with a bore which is adapted to receive a driving pin (not shown)as described above. A drive mechanism (such as those described herein)can be activated to rotate the pin and thus drive gears 506, whichrotates rotors 502, 503, and 504 in the directions shown by the arrows.Working end 500 includes stator 501. Rotor 504 includes hooked-shapedgrasper teeth 517 and 518 which when rotating pull tissue (not shown)into the device in the direction of arrow 509, but do not necessarilyrip the tissue. Graspers 517 and 518 rotate and pull the tissue towardsfixed hooked-shape blade 508 which is fixed to the inside of side of thehousing. Blade 508 is formed in the housing to fit between graspers 517and 518 as graspers 517 and 518 rotate past blade 508. As shown in FIG.40B, the tissue is compressed between the rotor and the wall of thehousing and is sheared by fixed blade 508 and graspers 517 and 518. Asrotor 504 continues to rotate, graspers 517 and 518, in combination withsolid wall guide wall 510, pull the tissue into a first area between therotors where it is allowed to expand, as illustrated in FIG. 40B.Stripper 511 extends from the housing wall and is formed in between theplanes of grasper 517 and 518. Stripper 511 may extend between graspers517 and 518 to a location that provides near contact with a centralrotating shaft of rotor 501 so as to inhibit passage of material fromthe interior of the working end to a position outside the working end.Stripper 511 preferably also has a configuration, e.g. slope or thelike, which helps remove material from graspers or blades 517 therebyhelping prevent the material from exiting the housing.

Grasper 520 on rotor 503 then grasps and pulls tissue towards the secondfixed blade 512, which is fixed to a second wall of the housing. Theprocess that occurred at the first fixed blade 508 is repeated again,and once again the tissue is then directed towards a third fixed blade515. Shredded material is directed proximally in the direction of arrow516, when it is extricated by a vacuum. In most the most preferredimplementation of the devices of the type exemplified in FIGS. 40A and40B, rotators that at located more proximally relative to the distal endof the working end preferably rotate at a faster rate than the next fordistal rotor and/or have more blade elements that can be used to extractmaterial from the grip of more distal blades and thus drive the materialdeeper into the working end and for some blade to further aid inreducing the size of the entrained material.

In variations of the embodiment of the FIGS. 40A and 40B, multiplerotors “n” may be located in parallel so that multiple rotors are usedto transport and breakdown material. The details of how this system ofrotors in series works is listed below.

The devices of the type of FIGS. 40A and 40B preferable include grippingblades shearing blades, externals stators internal stators of varyingthickness and spacing directing elements which are digitated or notalong with stripping element which are preferably digitated. The devicesalso include expansion areas which allow soft tissue to decompress orde-stretch while waiting for pick up or breakdown by a next series ofelements. In some embodiments, the fixed stators may be replace bymoving rotor elements. Internal stators may be used to shred incomingtissue at different levels of fineness. Progressive shredding maybeaccomplished by increasing the number of blade planes and stators foreach stage after the intake rotor or rotors. Progressive shredding andoutflow inhibition may also be accomplished by running the internalrotors at higher rates than that of the intake rotor and even that ofthe next more distal rotors. As illustrated in FIGS. 40A and 40B,directors 510, 511, 513, and 514 direct the material into the expansionareas where it will be ripped and pulled into the next set of rotors.Any excess material that is caught between the rotor blades of the firstshredder will be stripped and directed by be a stripper that isinterleaved with the blades rotor. The strippers 511 and 514 may act asa stators that void additional shearing. Directors 510. 511, 513 and 514are generally not interleaved with rotors but may be in someembodiments.

In the device of FIGS. 40A and 40B, tissue is pulled into the device byintake rotor, e.g. this may be defined as step 1. A second set ofstators 508 internal to the housing may provide tissue shredding. Asintake Rotor A continues around for the next exterior swath cut oftissue, potential tissue located in between the blades may be strippedaway by stripper 511 or by movement of blades 520. Tissue is directedinto an expansion region between rotors 504 and 503 and may be allowedto expand before being compacted and hooked by the next rotor 503.Tissue is cut or shredded from rotor 501 A by the motion of rotor 503,which may be defined as step 2. As noted above rotor 503 may be rotatingat a higher rate than rotor 504. Next the tissue is directed into thegap between rotors 503 and 502 and may be allowed to expand before beingcompacted and hooked by the next rotor 502. Tissue is sliced again by ahigher density blade on rotor 502, which may be defined as shreddingstep 3. Rotor 502 may be rotating at a higher rate than rotor 503. Theprocess of progressive, i.e. stepped, shredding may be continue throughn number of stages until tissue has reached a desired size and then theindividual particles of tissue may be extricated through the device byvacuum and or via irrigation.

While FIGS. 40A and 40B show three rotary devices in series, in someembodiments there are more or less than three rotary devices. In someembodiments there is more than one rotor at each stage. For example,there can be two sets of three rotors in series, with the two setsadjacent one another in the housing. This can potentially increase therate of tissue processing as well as provide more efficient shearing oftissue.

While gear 502 in FIG. 40 is the driving rotor, any of the rotors can bethe driving rotor, such as rotor 503. In some embodiments the rates ofrotor rotation is not 1:1. In some embodiments the most distal rotor(i.e., rotor 504 in FIG. 40) rotates faster than the other rotors. Forexample, rotor 503 can rotate at 10 times the speed of rotor 504, whichcan increase the speed with which the tissue is processed in thehousing. In embodiments in which the rotors rotate at different speeds,the gears which rotate the rotors may not be in the same train or may bein the same train with different diameters and teeth counts,alternatively multiple drive trains can exist.

FIG. 41 illustrates an alternative design in which a plurality of bladerotors 530 and 532 direct tissue (not shown) towards vertical cutters534 which are fixed in place (e.g., fixed to a housing in a working endof the device). Vertical cutters have sharp edges 535. After passingthrough vertical cutters, the tissue can be rotary sliced or passedagain through a second set of vertical column cutters or rotatingcutters.

FIG. 42 shows an alternative embodiment of a ‘hybrid’ blade with teeththat are capable of both piercing, or cutting, into tissue to entrainit. The outer portions of the teeth 552 and 551 are intended to cut thetissue, while the inner portion 553 is intended to entrain the cuttissue and convey it into the instrument. In some embodiments, the outerportions are thinner (e.g., formed from a single relative thinmulti-material layer) and the inner portion is thicker (e.g., formedfrom one or more multi-material layers). In some alternative embodimentsthe blade may have a non-symmetric shape based on the intendeddirections of motion and use.

FIG. 43 illustrates an optional blade stagger design in which the tipsof teeth 106 are staggered a distance “S” from one another measuredcircumferentially or in an offset angular increment relative to adjacentblade tips. When more than two blades are used in a blade stack, thedistance S for a pair of blades can be the same or can be different thanthe distance S for a different pair of blades.

In some embodiments the distal end of the working end can include morethan two blade rotors sets. In some embodiments blade stacks may bestacked on one another. For example, two blade stacks can be stacked onthe top of two other blade stacks for form a four rotor blade system.Additionally, the axis of rotation of the blade stacks are notnecessarily parallel to one another. For example, a working end can have4 blade stacks pointing in the distal axial direction but rotated withrespect to each other for example to having rotation axes rotating aboutshaft positioned on the hour hand of a clock located at “12 o'clock,”3o'clock, 6 o'clock, and 9 o'clock positions, wherein the axes ofrotation of the 12 o'clock and 6 o'clock rotors are parallel, and theaxes of the 3 o'clock and 9 o'clock rotors are parallel. One set of axesis perpendicular to the other set of axes. All four rotor sets may bedirecting the tissue centrally inward. In an alternative embodiment,there are three blade stacks and each is 120 degrees from each of theother blade stacks, and their axes of rotation form an equilateraltriangle at their points of intersection (e.g. 2 o'clock, 10 o'clock,and 6 o'clock).

In some embodiments blade tips, gear pins and other high wear surfacesmay be formed from a wear resistant material (e.g. rhodium or diamond)while other portions of the device may be formed from another materialthat is more suited to the functionality of the device as a whole (e.g.a more resilient or less brittle material, nickel cobalt, nickelphosphor, palladium).

In some embodiments, blades and/or blade stacks may rotate at differentrates or blades within a single stack may rotate at different rates.

In some embodiments the working end of the tissue removal device isformed with a length of about 4 mm, a width of about 2.5 mm and a heightof about 0.75 to 1.0 mm. In other embodiments the height may beincreased to several millimeters or decreased further, while the lengthand width may be increased many times (3-5 to even 10 times) or evendecreased. Stacks of shredders of different sizes (e.g. number ofshredding or intake rollers, or having diameters of such shredding orintake rollers) may be formed to provide a desired material interfaceconfiguration (e.g. cylindrical). Such configurations may have effectivecentral heights that approximate their widths. Such configurations mayhave, for example, rectangular configurations, stepped diamondconfigurations, stepped configurations approximate ellipses or circles(e.g. approximate the diameter of a delivery cannula.

In some embodiments portions of the working end are formed separatelyand then assembled. In some embodiment the working end is formed in afinal assembled state. In some embodiments the working end is coupled toother components of the delivery system (e.g., an introducer) afterassembly. In some embodiments components that move relative to oneanother are formed with fully or partially overlapping etching holes sothat improved flow paths are created for removing sacrificial material.

FIG. 44 illustrates an exemplary embodiment of components of a devicethat are formed in one configuration but separated from a finalconfiguration and are moved relatively toward one another after releasefrom sacrificial material. It may be desirable to form very small gapsbetween a rotating gear axial, shaft or boss relative to a surroundinghole, bushing or bearing. Due to minimum feature size limitation, directformation of moving components in desired configurations may bechallenging or not cost effective. FIG. 44 shows gear boss 650 andadjacent surfaces 652 and 654 in an “as-formed” spaced-apartconfiguration. Additionally, although not shown, the internal gearscould also be formed in a spaced-apart configuration from their adjacentmaterial. After fabrication, surfaces of material 652 and 654 are movedcloser to one another and locked in place by locking first lock element656 and second lock element 658. Gear boss 650 can then be disposed in afinal configuration closer to surfaces 652 and 654 than it would havebeen able exist in an “as-formed” configuration which was also the finalconfiguration.

FIG. 45 shows an exemplary embodiment in which a gear or boss isfabricated in an “as-formed” configuration in which it is out of planewith material which the gear or boss will ultimately be in-plane with ina final configuration after formation. Boss 660 is fabricated up and outof plane with 668, while gear 672 is fabricated out of plane with matinggear 670. Once fabricated, boss 660 is moved down into bore 662 so thatit is in-plane with surface 668, while gear 672 is moved down andin-plane with its mating gear 670. Appropriate clip or other retentionelements may exist to hold the components in their working positionsafter being moved there.

FIG. 46 illustrates an alternative embodiment similar to FIG. 44,wherein slide plate 684 includes protrusion 686 on one side adapted tofit within channel 668 Slide plate 684 is formed spaced apart from boss682, but after formation slide plate is slid into position, and the bossclearance is properly set. The slide plate can then be locked in place,such as by snap-locking or laser welding in place.

FIGS. 47A-47C illustrate an exemplary embodiment of a working end,including a gear train and two shredder rotors. FIG. 47A shows workingend 700 in an “as-formed” configuration with elements spaced apart tofit minimum feature size limitation. Working end includes first section704 and second section 702 spaced apart from one another, first boss710, first blade stack 706, second blade stack 708, second boss 712, andpin bore 714 in first section 704. FIG. 47B shows driving gear 716, gear718, and gear 719 in their as-formed configuration. The gears are formedspaced apart in order to create the proper gap dimensions between theteeth. FIG. 47C shows the design in a closed, final configuration inwhich section 704 and 702 are moved closer which reduces the gapsbetween surfaces of sections 704 and 702 and bosses 710 and 712. Thegear teeth are also moved closer to one another (not shown).

In some embodiments gap layers (i.e. intermediate tiers) may, forexample, be as little as about 2 microns or as much as about 10 microns,and more preferably be in the range of about 4 microns to about 6microns. Non-gap layers may, for example, be as large as about 20microns to about 50 microns or more, while in some embodiments thenon-gap layers may preferably in the range of about 20 microns to about30 microns.

FIGS. 48A-48C illustrate an embodiment of a tissue removal deviceincluding a core cutting saw 740 with a plurality of tissue removaldevices 742 therein. The device includes core cutting saw 740 with teeth741 formed in its distal end, wherein the saw 740 is adapted to rotatein the direction of the arrow shown. The core saw is cutting to theouter diameter of the device, where the tissue removal devices are notadapted to cut to that diameter. The tissue removal devices aredirecting material inside their housings and processing it for transportto the proximal end of the device. FIG. 48B depicts one of the removaldevices of FIG. 48A wherein element 748 rotates with it bladeinterdigitated with the blades on the stator as it forces material intothe remover. FIG. 48C shows the assembly of a rotating saw, a joinedrotating gear that engages drive gears on the removing devices which arefixed, or at least move at different rotational rates relative to thesaw and cylindrical gear FIGS. 48A and 48B. The working end (i.e. theremoving elements) may be fixed or non-rotating, rotating opposite tothe saw or simply rotating at a different speed relative to the saw.

In some embodiments the etching holes in the working end may be sealedafter release of sacrificial material.

In some embodiments of the working ends of the tissue removal devicesset forth herein, may include holes, textures, grooves, or otherfeatures which provide rotating elements, the shafts on which theyrotate, and/or to the surfaces surrounding the rotating elements withconfigurations that allow for aerodynamic or hydrodynamic bearingsurfaces that reduce friction during rotation of the elements.

In some embodiments, the tissue removal devices may be configured toremove soft tissue without damaging hard tissue, either by use ofselective blade configurations, operational speeds, and/or via clutchelement that halt rotation of removal elements if encountered tissuedoes not have the anticipated properties. Such clutch mechanism may bemechanical in nature or implemented via sensor input and associatedmotor control.

Some embodiments of the disclosure relate to devices and methods forremoving tissue from the human spine (e.g., the lumbar or cervicalspine). Such methods may be minimally invasive while others may not.Tissue removal devices such as the various shredder devices discussedabove may be used to remove tissue such as ligament, bone, cartilage,tendon, and disc (both nucleus and annulus), as well as fat, fascia, andmuscle in the area of the spine. Removal of such tissue may be a part ofmedical procedures for repairing a bulging or herniated discs, forrepairing spinal stenosis, or for other indications.

In some embodiments, a tissue removal device may be delivered to adesired surgical site via a rigid, flexible, steerable, or articulatedstructure, while optically visualizing the procedure using a rigid,flexible, steerable, or articulated endoscope that is separate from theremoval device. In some embodiments, a tissue removal device may bedelivered to a desired surgical site through a working channel, oralongside, a rigid, flexible, steerable, or articulated endoscope usedto visualize the procedure. In some embodiments, the tissue removaldevice may be introduced under fluoro guidance or guidance fee anotherimaging method.

In some embodiments, a tissue removal device may be delivered to adesired surgical site through a rigid, flexible, steerable, orarticulated structure and also incorporate one or more (e.g., two forstereoscopic visualization) imaging means such as a CCD or CMOS imagingchip, a fiber optic bundle, or single fiber endoscope (e.g., using thespectrally-encoded endoscope technology developed by the Wellman Centerfor Photomedicine of Mass General Hospital), along with suitable opticssuch as lenses. The imaging devices may be located so that the opticalaxis substantially coincides with the centerline of the tissue removaldevice, or be offset from the centerline of the device. In someembodiments, the procedure may be visualized by the use of X-rays (e.g.,fluoroscopy or CT scanning), ultrasound, MRI, or other imagingmodalities, in addition to, or in lieu of, optical visualization viaendoscopes or other imaging means as described above.

In some embodiments, to enhance visualization, a transparent dome thatis hemispherical, wedge-shaped, or is otherwise appropriately shaped maybe provided to protect the optics and to provide a means fordisplacing/retracting/dissecting tissue as the device is pushed forward.Irrigation and/or mechanical action may be used in some embodiments tokeep the dome clean.

In some embodiments, the tissue removal device is activated (e.g.,shredder cutters rotated) only once it has been delivered to thesurgical site; prior to activation, it may be allowed to contact tissue(e.g., en route to the site). In some embodiments, the device may beprotected from tissue contact by retracting it inside a sheath, tube,catheter, or similar structure. In some embodiments, the tissue removaldevice may include fixed or moveable shields or shutters which move outof the way to allow device use, prevent damage to surroundingstructures, in some cases exposing only the tissue to be processed bythe device.

In some embodiments, it is desirable to simultaneously remove tissuefrom a wider area than is possible with the previously-disclosedShredder. In such embodiments, a shredder that is larger in width and/orheight may be used, and may involve more than two groups of rotatingcutters. In some embodiments, if the desired height exceeds that whichis practical to achieve using multi-layer multi-material electrochemicalfabrication methods as a single structure, two or more shredders may bestacked and operated as one.

Stacked shredders may be aligned, and joined by methods such as laserwelding, fasteners such as screws and rivets, swaging of featuresdesigned for joining, soldering, brazing, and adhesives. Such stackeddevices may be joined by connectors (e.g. male and female engagementelements formed with the devices themselves and engaged by stack mereact of aligned stacking. In other embodiments, engagement may occurafter stacking by deploying components formed with the devices on aselective basis. In some embodiments, disengagement of stacked devicesmay also be possible. In such stacked device embodiments, gear trainsmay be driven independently (e.g., at different speeds or the samespeeds, with correlated phase or uncorrelated phase) or jointly. Inembodiments in which the gear trains of joined shredders are drivenjointly, this may be accomplished when joining the shredders by aligningthe holes in the driven gears (which receive a drive shaft) and drivingall driven gears with an elongated shaft. Alternatively, the drivengears may be designed to be attached or keyed to one another so thatwhen one or more is driven by a drive shaft, all spin together.Shredders designed to be stacked may incorporate upper and/or lowerplates which are thinner (e.g., half the thickness or less) than if theshredder were designed for independent use, so that the combinedthickness of the upper plate of one shredder and the lower plate of theshredder above it is not excessive. If the stacked shredders areintended to form a cylindrical device (e.g., to remove tissue in acylindrical volume when plunged) or to occupy as much as possible of acylindrical lumen (e.g., sheath or working channel), then the shreddersmay be designed as shown in the example of FIG. 49 which provides aschematic view of the distal or working end of a plurality of stackedshredders where each shredder is sized to conform roughly to acylindrical overall shape. The working end is located within a sheath801 (e.g. a catheter or other lumen and may be extended from the sheathas appropriate. The working end, in this example, include doubleshredders 811-815 wherein a portion of the shredders may have differentconfigurations to provide an overall device or working end configurationof desired shape

In some embodiments, in order to increase the hardness of the devicewhere in contact with tissue (especially for hard tissue such as bone),the contacting surfaces may be made from harder material, or have acoating of harder material. Such materials include electroplatedrhodium; vacuum-deposited nitrides, carbides, and oxides; and diamond,boron nitride, or other hard ceramic particles in a matrix of metal(e.g., co-deposited with electroless nickel) or resin.

In some implementations, jamming of the tissue removal device withtissue may be an issue. In some embodiments, reversing (e.g.,periodically or as-needed) the direction of the motion (e.g., theshredder cutters) may help to dislodge tissue causing jamming. In someembodiments, tissue caught within the shredder cutters or similarstructures, that might lead to jamming, could be dislodged/stripped fromthe cutters by suction, directed irrigation, or mechanical structuressuch as wiping or reciprocating elements.

While some tissue removal devices may not just cut tissue, but alsocapture and transport it away from the surgical site, in someembodiments suction capability (e.g., vacuum holes and manifoldinterfaced to a vacuum pump, peristaltic pump, etc.) may be incorporatedinto the device to facilitate removal of processed material. In someembodiments the tissue removal device may be interfaced to a devicehaving the ability to mechanically transport tissue (e.g., anArchimedes-type screw rotating within a sheath) larger distances (e.g.,to outside the body) than the device itself.

In some embodiments, the surgical approach to the tissue to be removedmay be substantially anterior or anterior oblique, while in someembodiments, it may be substantially posterior or posterior oblique.

In embodiments relating to spinal disc problems, closure of the annulusof the disc after removal of disk material (e.g., disc nucleus) may beperformed, for example, using suture material, or a tissue approximationdevice such as a clip, staple, or ratcheting fastener.

In variations of some of the above noted embodiments the effectivecutting, shredding or removal area of a device may be adjustable, forexample, by inclusion of an adjustable window on the removal deviceitself or on the catheter. Adjustability of a device may also allowdifferent teeth configurations (shape and or size) to take moreprominent positions depending on the type of tissue to be processed. Insome embodiments the same catheters that provide the tissue removaldevices may also provide suction or irrigation to be incorporated intothe same catheter)

In some embodiments, material extraction from a working site may occurby back and forth motion at different angles which are varied by varyingthe entry angle of a relative rigid insertion element. In otherembodiments, the tissue removal device may be located on flexible orguidable element that may be made to change shape by control wires orthe like which can cause the device to bend to the left of the rightwhile other movement may be obtained by rotating the device about itsaxis or by moving it back and forth. In some embodiments, the guidableelement may be moveable up, down, and left and right directions byappropriate manipulation. In still other embodiments, for example, asingle drive shaft operating all removal elements may be engaged by arotating element and the device may be pivotable to the left or right bynearly 180 degrees by the extension or retraction of control wiresengaged with the side of the device. Such devices would preferablyinclude flexible or pivotal lumen elements that would allow appropriateextraction of material (e.g. via vacuum) along with possible applicationof irrigation for blade cleaning or material extraction regardless ofthe pointing direction of the distal end of the shredder. Such apivotable device would allow access to forward, side facing, and backfacing regions for tissue removal.

The operation of removal devices in removal procedures as set forthherein may be done under the manual control of a physician or operatorwherein movement and extraction occur via a series of movements selectedby the operator. Alternatively, the extraction may occur via a computerdefined and controlled algorithm that directs the shredder through aseries of predefined motions and operations or via a series of motionsand operations that are dictated at least in part by sensor retrievedinput (e.g. visually, optically, conductively, capacitively,magnetically, or the like).

FIGS. 50A and 50B provide a schematic illustration of a shredding ortissue removal device, i.e. working end, 854 located within a lumen 853having an expanded distal end 852 and a smaller lumen 851 which may beused to feed additional tools or elements into or beyond the expandeddistal end of the lumen. The expanded distal end may be of fixed size ormay be controllable.

FIGS. 51A and 51B provide close (compacted) and open (expanded) views ofa sample device according to a procedural embodiment of the disclosure.The device includes an elongate delivery rod, tube or wire that may alsoprovide control functionality along with an expandable mesh or net likeelements that can be move from a contracted state 862C to an expandedstate 862E.

FIGS. 52A-52F illustrate the use of the devices of FIGS. 50A-50B and51A-51B in a thrombectomy application. FIG. 52A depicts the device ofFIGS. 50A and 50B inserted into a vessel containing a thrombus 871wherein the distal end 852 of the device is located in proximity to thethrombus. Next, in FIG. 52B, a guidewire or lumen 872 is extendedthrough and from lumen 254 though and beyond the distal end of thethrombus. In FIG. 52C the closed expander 862C is shown extending beyondthe distal end of the thrombus after which it is manipulated to attainopen state 862E. In FIG. 52E, the thrombus is shown being drawn in tothe catheter so that it may be macerated by the shredder 854. FIG. 52Fshows the state of the process after partial destruction and removal ofthe thrombus has occurred with a portion of it 871S being drawn down thelumen 851. Continued process will result in complete maceration of thethrombus or at least sufficient maceration to allow extraction of theremaining portion to safely occur (e.g. via entrapment in the distal end852 of lumen 851.

FIGS. 53A-53D show another exemplary embodiment of a tissue removaldevice. Device 5310 may employ any of the cutting heads describedherein, or other suitable cutting heads. In some embodiments, a doublerotor shredding head is employed at the distal end of device 5310 toselectively debride tissue down to the cellular level.

In this exemplary embodiment, handheld device 5310 includes a steppermotor 5312 at its proximal end. In other embodiments, other types ofelectric, pneumatic or hydraulic motors, servos, or other prime moversmay be used. The proximal end of motor 5312 may be provided with amanually turnable thumbwheel 5314, as shown. In this embodiment, thedistal output end of motor 5312 is provided with a housing 5316, whichis made up of a front cover 5318 and a rear cover 5320. Located distallyfrom housing 5316 are an outer shaft housing 5322, an outer shaft lockseal 5324, and a support clamp 5326. A non-rotating, outer support tube5328 extends from within the proximal end of device 5310 towards thedistal end of the device. Within support tube 5328, a rotating drivetube 5330 (best seen in FIGS. 53B and 53C) also extends from within theproximal end of device 5310 towards the distal end of the device. Thesupport tube 5328 and inner drive tube 5330 may collectively be referredto as an introducer. A cutter head assembly 5332, subsequently describedin detail, is attached to the distal end of support tube 5328.

As best seen in FIG. 53B, other components of device 5310 include motorshaft drive axle 5334, motor dog 5335, four bearings 5336, drive gear5338, driven gear 5340, inner drive shaft axel 5342, inner shaft lockseal 5344, vacuum gland disk 5346, vacuum seal lock housing 5348, vacuumseal lock 5350, vacuum hose barb 5352, irrigation fluid hose barb 5354,outer tube o-ring 5356, and two vacuum gland o-rings 5358. Various otherpins, dowels, fasteners, set screws, ball detents, shims and wave discsprings are shown in the figures without reference numerals. As will beappreciated by those skilled in this art, these non-referencedcomponents serve to align, retain and ensure the proper functioning ofthe other components of exemplary device 5310.

The two rotors of cutter head assembly 5332 located at the distal end ofdevice 5310 are driven by motor 5312 through drive tube 5330 and otherdrive components of device 5310, as will now be described in moredetail. As best seen in FIGS. 53B and 53C, a motor dog 5335 is attachedto the output shaft of motor 5312. Motor dog 5335 is coupled to motorshaft drive axle 5334, which is rotatably mounted in housing 5316 withtwo bearings 5336. Drive gear 5338 is rigidly fixed to motor shaft driveaxle 5334, and drives driven gear 5340 (as best seen in FIG. 53D.)Driven gear 5340 is rigidly fixed to inner drive shaft axel 5342, whichis rotably mounted in housing 5316 with two bearings 5336. Innerrotating drive tube 5330 passes through the center of inner drive shaftaxel 5342 and is rotatably fixed thereto. Drive tube 5330 extends fromthe proximal end of device 5310 to the distal end of the device throughthe non-rotating outer support tube 5328. The distal end of drive tube5330 (or a separate tube 5330′ attached thereto) is provided with crownteeth around its periphery, as shown in FIGS. 54B and 56C, for meshingwith drive gear 5410. As drive tube 5330 is rotated about a longitudinalaxis of device 5310 by motor 5312 through the above-described drivetrain components, it drives drive gear 5410 about an axis that isperpendicular to the longitudinal axis, as can be appreciated by viewingFIG. 56C. Drive gear 5410 in turn drives other components of the cutterhead assembly, as can be appreciated by viewing FIG. 56E, and as issubsequently described in more detail.

In some embodiments motor 5312 is provided with feedback control forrotational velocity and torque. These two parameters can be used forcontrolling and monitoring changes in rotational velocity and the torqueload. For measuring rotational velocity, an encoder may be located atone or more of the cutter rotors, at the drive motor, or at anotherlocation along the drive train between the drive motor and cutterrotors. In some embodiments, the encoder is located at or close to therotors to avoid backlash associated with the drive train, thereby makingthe velocity monitoring more responsive and accurate. Encodertechnologies that may be used include optical, resistive, capacitiveand/or inductive measurement. To sense torque load, one or more straingages may be located at the cutter rotors, at the drive motor, or atanother location along the drive train between the drive motor andcutter rotors. Torque load may also be sensed by monitoring the currentbeing drawn by the motor. By sensing changes in velocity and/or torque,a controller associated with device 5310 can determine that the cutterrotors are passing from one tissue type to another and take appropriateaction. For example, the controller can sense when the cutter elementsare passing from soft to hard tissue, from hard to medium densitytissue, or from a cutting state to non-cutting state. In response tothese changes, the controller and/or device 5310 can provide audio,visual and/or tactile feedback to the surgeon. In some embodiments, thecontroller can change the velocity, direction or stop cutter rotors fromrotating in response to velocity and/or torque feedback. In oneembodiment of the invention, a typical cutting rotor speed is on theorder of 100 to 20,000 rotations per minute, and a typical torque loadis on the order of 0.25 to 150 mN-meter. Other sensors, such as apressure sensor or strain sensor located at the distal tip of device5310, may also be utilized to provide feedback that tissue cuttingelements are moving from one tissue type to another. In someembodiments, an impendence sensor may be located at the distal tip ofthe device, to sense different tissue types or conditions, and providecorresponding feedback for tissue cutting control when the tissue beingcut by the cutter head changes. Such a pressure sensor feedback controlarrangement can be used with types of cutting devices other than thosedisclosed herein.

Referring now to FIG. 53C, irrigation fluid hose barb 5354 is providedon the lower side of outer shaft housing 5322 of exemplary device 5310.Hose barb 5354, or a similar fluid line coupling, may be connected to asupply of irrigation fluid. The lumen of hose barb 5354 is in fluidcommunication with an internal irrigation fluid cavity 5360. Fluidcavity 5360 surrounds internal drive tube 5330, and is bounded on itsproximal end by o-ring seal 5358 around drive tube 5330. Fluid cavity5360 is bounded on its distal end by o-ring seal 5356 around outersupport tube 5328. This arrangement allows drive tube 5330 to rotate,but constrains irrigation fluid delivered from hose barb 5354 to travelonly through the annular space defined by the outer surface of drivetube 5330 and the inner surface of support tube 5328. Irrigation fluidmay thus flow distally through the annular space to the distal end ofdevice 5310.

As shown in FIGS. 54B and 56A, one or more drive aligner rings 5412 maybe provided between outer support tube 5328 and inner drive tube 5330along their lengths to support drive tube 5330 as it rotates. In orderto allow the flow of irrigation fluid between the tubes 5328 and 5330,rings 5412 may be provided with one or more channels 5414 as shown. Whenthe distal flow of irrigation fluid reaches the cutter head assembly5332, it continues to flow distally into lug 5416. To enable the fluidflow, lug 5416 is provided with fluid channels 5418 located along theouter walls of its central bore, as best seen in FIGS. 54C, 55C. As canbe appreciated by viewing FIG. 56C, irrigation fluid passes distallybetween inner drive tube 5330 and lug 5416 through channels 5418 (onlyone channel shown in FIG. 56C). As shown in FIG. 56B, irrigation fluidflowing distally through channels 5418 is directed toward the outsideportions of cutting elements. In this embodiment, the outside portionsof cutting elements are rotating distally, away from the fluid flow,while the inside portions of cutting elements are rotating proximally,toward the center of lug 5416 and drive tube 5330.

In some embodiments, the irrigation fluid serves multiple functions. Theirrigation fluid can serve to lubricate the cutting elements, drivegears, journal bearings and other components as the parts rotate. Theirrigation fluid can also serve to cool the cutting elements and/or thetissue being cut, absorbing heat and carrying it away as the irrigationfluid is removed from the patient. The fluid can serve to flush tissueparticles from the moving parts to prevent them from becoming clogged.The fluid can also serve to carry away the tissue portions being cut andremove them from the target tissue site. In some embodiments, theirrigation fluid is discharged from the cutting device and may beremoved from the target tissue site with other, traditional aspirationmeans. With the current exemplary cutting device 5310, however, theirrigation fluid and/or other bodily fluids may be removed from thetarget tissue site by the cutting device 5310, as will now be describedin detail.

As previously described, irrigation fluid may be delivered to cuttingelements and/or a target tissue site through device 5310. Exemplarydevice 5310 is also constructed to remove the irrigation fluid andtissue portions cut from the target tissue site through the shaft ofdevice 5310. As can be appreciated by viewing FIGS. 56B and 56F, the twointerleaving stacks of cutting elements, also referred to as rotors 5610and 5612, have an overlapping section 5614 in the center of cutter headassembly 5332. The two rotors 5610 and 5612 may be rotated in oppositedirections (as depicted by arrows A and B in FIG. 56F) such that eachrotor engages target tissue and pulls it towards the central overlappingsection 5614. In overlapping section 5614, the tissue is shredded intosmall pieces by the interdigitated cutting elements, as is subsequentlydescribed in more detail. The small tissue portions are generallypropelled in a proximal direction by rotors 5610 and 5612, away from thetarget tissue site and into the cutter head assembly 5332. As can beappreciated by viewing FIG. 56B, the shredded tissue portions emergefrom rotors 5610 and 5612 substantially along the central axis of lug5416 (and therefore also the central axis of drive tube 5330. Withsufficient irrigation fluid being supplied to the tissue cutting area,and sufficient aspiration being provided from the proximal end of thedevice, irrigation fluid around rotors 5610 and 5612 carries the cuttissue particles proximally down the center of drive tube 5330. As shownin FIG. 53C, the proximal end of drive tube 5330 is in fluidcommunication with hose barb 5352 located at the proximal end of device5310. A traditional aspiration device or other suction source may beattached to device 5310 through hose barb 5352 or other suitable fluidcoupling to collect the spent irrigation fluid and cut tissue portions.

In some embodiments, the cut tissues portions emerging from hose barb5352 may be collected for testing. The tissue portions may be separatedfrom the irrigation fluid, such as by centrifugal force, settling and/orfiltering. The tissue portions may be measured to precisely determinethe mass and/or volume of tissue removed. The pathology of some or allof the tissue portions may also be determined. In some embodiments, theabove testing may be performed during a surgical procedure so thatresults of the testing may be used to affect additional stages of theprocedure.

According to aspects of the invention, the inside diameter of drive tube5330 may be much larger than the maximum dimension of the tissueportions traveling through it. In some embodiments, the maximum tissuedimension is less than about 2 mm across. In one exemplary embodiment,the inside diameter of drive tube 5330 is about 3 mm, the outsidediameter of the support tube 5328 is about 5.6 mm, and the maximumdimension of the tissue portions is about 150 microns. In anotherexemplary embodiment, the inside diameter of drive tube 5330 is about1.5 mm, the outside diameter of the support tube 5328 is about 2.8 mm,and the maximum dimension of the tissue portions is about 75 microns. Inother embodiments, the inside diameter of drive tube 5330 is betweenabout 3 mm and about 6 mm. In some embodiments, the maximum dimension ofthe tissue portions is at least one order of magnitude less than adiameter of the tissue removal lumen. In other embodiments, the maximumdimension of the tissue portions is at least twenty times less than adiameter of the tissue removal lumen. In some embodiments, the maximumdimension of the tissue portions is less than about 100 microns. Inother embodiments, the maximum dimension of the tissue portions is about2 microns.

Referring now to FIGS. 54A-54C, an exemplary cutter head assembly 5332is described in more detail. Cutter head assembly 5332 may be used withdebriding device 5310, shown in FIGS. 53A-53D. As best seen in FIG. 54B,cutter head assembly 5332 includes lug 5416, drive gear 5410, rotorhousing assembly 5420, aligner pin 5422, and aligner cap 5424. Lug 5416is provided with a cutout on its distal end for receiving rotor housingassembly 5420. Beneath the rotor housing cutout, lug 5416 has a circularrecess for receiving drive gear 5410. A bore is provided in the bottomof lug 5416 for receiving the head of aligner pin 5422. When cutter head5332 is assembled, the shank of aligner pin 5422 passes through the boreof lug 5416, through a square aperture in the center of drive gear 5410,through a bore in the proximal end of rotor housing assembly 5420, andinto a large diameter bore through the top of lug 5416. Aligner cap 5424is received with the large diameter bore in the top of lug 5416, and isfastened to aligner pin 5422 by a press fit, weld, threads, a separatefastener, or other suitable means. In this assembled arrangement, bestseen in FIG. 56H, pin 5422 and cap 5424 retain rotor housing 5426 frommoving longitudinally relative to the central axis of the instrument,and rotor housing 5426 and drive gear 5410 retain pin 5422 and cap 5424from moving radially relative to the central axis of the instrument. Pin5422 and cap 5424 spin together as a unit relative to lug 5416, andserve to align drive gear with the distal end of drive tube 5330′, aspreviously described. Pin 5422 also serves to transmit torque from drivegear 5410 to gear 5616, which resides inside the rotor housing directlyabove drive gear 5410, as shown in FIG. 56H.

FIGS. 55A-55D show further details of lug bearing 5416, which forms thebase of cutter head assembly 5332, shown in FIGS. 54A-54C. Assubsequently described in further detail, various different cutter headsmay alternately be inserted into and securing within the slot shapedopening in the distal end of the lug bearing.

FIGS. 56A-56H show the overall construction and operation of the variouscomponents of the rotor housing assembly 5420, and their interactionwith the other components of the cutter head assembly 5332, shown inFIGS. 54A-54C. The device of this embodiment utilizes two front cuttingrotors. The two rotors are driven inward toward one another at similarspeeds. The rotors are situated approximately perpendicular to theinline axis. This device may be referred to as a shredder.

FIG. 56A is a distally looking axial view showing the relationship ofouter support tube 5328, drive aligner ring 5412 and inner drive tube5330. FIG. 56B is a distally looking axial view showing the relationshipbetween rotor housing 5426, lug 5416, and other components of the cutterhead assembly 5420. FIGS. 56C-56G are a series of oblique,cross-sectional views taken at various elevations through the cutterhead assembly 5332, showing the various layers of components progressingfrom the bottom to the top of the assembly. Starting with FIG. 56C, lug5416 and drive tube 5330′ are shown in cross section with the rotorhousing assembly 5420 removed to expose drive gear 5410. As previouslydescribed, drive gear 5410 resides in a circular cutout within lug 5416and is driven by crown teeth located on the distal end of drive tube5330, or a component 5330′ connected to the distal end of drive tube5330. Drive gear 5410 mates with a square shank portion of aligner pin5422, which passes through a square aperture in the center of drive gear5410, thereby rotatably driving pin 5422. FIG. 56D shows a bottom plateportion of rotor housing 5426 residing in its cutout within lug 5416 andcovering most of drive gear 5410. A pair of apertures is providedthrough the bottom plate portion of rotor housing 5426 to rotatablyreceive axels 5618, 5618 from rotor assemblies 5610 and 5612. FIG. 56Eshows gears 5616, 5620 and 5622 rotatably mounted on the bottom plateportion of rotor housing 5426. Gear 5616 has a square, central aperturefor receiving the square shank portion of aligner pin 5422. As can beseen, gear 5622 meshes with gear 5620, which in turn meshes with gear5422. With this arrangement, drive tube 5330 or end component 5330′drives drive gear 5410, which drives aligner pin 5422, which drives gear5616, which drives gear 5620, which drives gear 5622. Gears 5620 and5622 each drive an axel 5618, which in turn drive rotors 5610 and 5612,respectively, in opposite directions as shown in FIG. 56F by arrows Aand B. As can be seen in FIG. 56E, gear 5622 has a smaller pitchdiameter than that of gear 5620 in this embodiment, which causes rotor5612 to spin at a faster rotational velocity than that of rotor 5610. Inother embodiments, the rotors may be driven at the same rotationalvelocity. As can be appreciated by viewing FIGS. 56E and 56F, a middleplate portion of rotor housing 5426 separates gears 5616, 5620 and 5622(below the plate) from rotors 5610 and 5612 (above the plate). FIG. 56Fshows rotor housing fins 5624 and 5626 interleaved between each of theblades of rotors 5610 and 5612, respectively. Fins 5624 and 5626 serveto guide cut tissue portions toward the center of drive tube 5330,rather than allow them to exit through the sides of the rotor housingand back into the patient. FIG. 56G shows the top plate portion of rotorhousing 5426 covering most of rotors 5610 and 5612, with rotor axels5618, 5618 and aligner pin 5422 protruding through. It can be seen bycomparing FIGS. 56F and 56G that the blades of rotors 5610 and 5612protrude further in the distal direction from the top plate portion ofrotor housing 5426 than they do from the middle plate portion. In otherembodiments, the protrusion distances can be equal, or reversed fromthose shown in FIG. 56G. In some embodiments, the blades may protrudefrom the housing by up to 500 microns. In other embodiments, the bladescan be recessed from one or both portions of the rotor housing, assubsequently discussed in more detail.

FIG. 56H shows a cross-sectional view taken along a vertical centerlineof the cutter head assembly 5332.

FIGS. 57A-57J show further details of an exemplary rotor housingassembly 5420′. Assembly 5420′ is constructed and operates in a mannersimilar to assembly 5420 as previously described in reference to FIGS.54A-54C and 56A-56H, but has a different blade configuration. As shownin FIG. 57A, rotor housing assembly 5420′ includes a pair of rotors5610′ and 5612′, each rotatably mounted in rotor housing 5426 by an axel5618. In this embodiment, rotors 5610′ and 5612′ are configured torotate in opposite directions to draw tissue into a center, overlappingregion where the tissue is shredded.

Referring to FIGS. 57B and 57C, the components of rotor housing assembly5420′ are shown. Assembly 5420′ includes housing 5426, a pair of axels5418, and gears 5410, 5620 and 5622, as previously described. Rotor5610′ includes two blades 5710 interspersed with three spacer rings 5714on first axel 5418. Rotor 5612′ includes three blades 5712 interspersedwith two spacer rings 5716 on second axel 5418.

It should be noted that while rotor housing assembly 5420′ is shown inan exploded format for clarity in FIGS. 57B and 57C, suggesting that thecomponents are fabricated separately and then assembled usingtraditional assembly processes, this may or may not be the case,depending on the embodiment. In some embodiments, rotor assembly 5420′is assembled this way. In other embodiments, assembly 5420′ may be builtin layers, such as by using the MEMS fabrication processes describedearlier in this disclosure. For example, after portions of housing 5426and gears 5410, 5620 and 5622 are built up in layers, bottom blade 5712,bottom spacer 5714, and housing fin 5624 are formed together in one ormore layers. Following this layer, bottom blade 5710, bottom spacer5716, and bottom housing fin 5626 may be formed together in one or morelayers. The process may be repeated until the entire rotors 5610′ and5612′ and surrounding components are formed. A thin sacrificial layermay be formed between adjacent layers of components to separate thecomponents from one layer from components of adjacent layers.Sacrificial material may also be formed in portions of eachnon-sacrificial layer to separate components on that layer, createdesired voids in the finished assembly, and to provide a substrate forforming components in subsequent layers above. With such a fabricationtechnique, rotor 5610′ may be formed as a single unitary structureinterleaved with portions of rotor housing 5426, rather than separatecomponents (i.e. axel 5418, spacers 5714, blades 5710, and gear 5620.)Similarly, rotor 5612′ may be formed as a single unitary structureinterleaved with portions of rotor housing 5426, rather than separatecomponents (i.e. axel 5418, blades 5712, spacers 5716, and gear 5622.)In some embodiments, combinations of fabrication and assembly techniquesmay be used to create the rotor housing and/or cutter head assemblies.

Referring to the top view shown in FIG. 57D and the bottom view shown inFIG. 57E, it can be seen that in this embodiment the axel 5418 of rotor5612′ is more distally located than axel 5418 of rotor 5610′. It canalso be seen that while a top plate portion of rotor housing 5426 coversmost of rotor blades 5710 and 5712, the blades protrude less from amiddle and bottom plate portion of housing 5426. Further details ofprotruding blades and rotor characteristics are subsequently discussedin reference to FIG. 57J.

Referring to the side view shown in FIG. 57F, it can be seen that thethree blades 5712 of rotor 5612′ are interleaved in a proximal region byrotor housing fins 5626, in a central region by spacers 5716, and in anopposite side region (seen only in a distal region of the blades in FIG.57F) by blades 5710 of opposing rotor 5610′.

A front or distal end view is shown in FIG. 57G and a rear or proximalend view is shown in FIG. 57H. As depicted in FIG. 57G, very small gapsor interference fits 5717 between overlapping blades 5710 and 5712 aredesirable in some embodiments. Similarly, very small gaps orinterference fits 5719 between blades 5712 and adjacent portions ofrotor housing 5426 are desirable in some embodiments, as will besubsequently described in more detail.

FIG. 57I shows a cross-sectional plan view of the gear train located inthe lower portion of rotor housing 5426 of assembly 5420′.

Referring to the cross-sectional plan view of FIG. 57J, the bottom twoblades 5712 of rotor 5612′ and the bottom blade 5710 of rotor 5610′ areshown. As shown, blades 5710 have a larger outer diameter than that ofblades 5712. But because axel 5418 of rotor 5612′ is located moredistally than axel 5418 of rotor 5610′, blades 5712 protrude moredistally from the bottom of rotor housing 5426 than do blades 5710 ofrotor 5610′. It can also be seen that teeth 5718 and associated troughs5720 of blades 5712 are configured to be rotationally out of phase withthose of other blades 5712 of rotor 5612′. As will subsequently bediscussed in more detail, this arrangement can tune rotors 5612 toselective cut certain types of tissue and avoid cutting other types oftissue.

Various rotor gaps can be seen in FIG. 57J. For example, gap 5722 isshown between the tips of blade teeth 5718 of rotor 5612′ and spacerring 5714/axel 5418 of opposing rotor 5610′. Gap 5724 is also shown,between the tips of blade teeth 5718 of rotor 5612′ and the adjacentportion of housing 5426. Gap 5726 is also shown, between spacer ring5714/axel 5418 of rotor 5610′ and the adjacent portion of housing 5426.In some embodiments, it is desirable to keep gaps 5722, 5724 and 5726very small, to ensure that tissue portions/particles that pass throughrotors 5610′ and 5612′ are first cut to a very small size, and to avoidjamming or clogging rotors 5610′ and 5612′. In some embodiments, thesegaps are fabricated as small interferences between the adjacent parts sothat when the rotors are first rotated, the adjacent parts hit eachother and wear down or burnish each other. In this manner, after a breakin period, smaller interference or zero clearance fits are createdbetween the adjacent moving parts. Gap distances that applicants believeare advantageous include less than about 20 microns, less than about 10microns, less than about 5 microns, less than about 1 micron,substantially zero, an initial interference fit of at least 2 microns,and an initial interference fit of about 5 microns.

In operation, the cutter elements of rotor housing assembly shown inFIGS. 57A-57J serve to grab tissue from a target source, draw the tissuetowards a central region between the blades, cut the tissue from thesource, and morcellate the tissue in small pieces for transport awayfrom the body. In other embodiments, separate cutter elements may beused for these various functions. For example, one blade or blades maybe used to cut tissue from the source, while another blade or set ofblades may be used to morcellate the cut tissue.

Components of cutter head assembly 5332, including rotor housingassemblies 5420 and 5420′, may be fabricated using processes such aslaser cutting/machining, photo chemical machining (PCM), Swiss screw,electro-discharge machining (EDM), electroforming and/or other processesfor fabricating small parts. Wafer manufacturing processes may be usedto produce high precision micro parts, such as EFAB, X-ray LIGA(Lithography, Electroplating, and Molding), and/or UV LIGA.

FIGS. 58-65 depict various other aspects of cutting blades useful forselective tissue removal, according to aspects of the invention.

In some embodiments, the key to the shredder's ability to selectivelyremove tissue is attributed to the protrusion of the rotating cuttersfrom the housing and the design of a tooth pitch (space between the tipsof adjacent teeth) of each rotor. In some embodiments, the protrusionsets the depth of the inward cut for the tips of the rotor. This inwarddepth controls the thickness of tissue being removed. The tooth pitch ornumber of teeth circumferentially about the rotor diameter provides anopening for individual tissue fibers and/or fiber bundles to be hooked,tensioned and drawn between the cutters.

From the point of view of the selected tissue, the tooth pitch andprotrusion may be designed to grasp the smallest fibers or fiber bundlesthat are to be removed. From the point of view of the non-selectedtissue, the tooth pitch may be many times smaller than the fiber orfiber bundle, and the protrusion may also be equally smaller than thefiber/bundle diameter.

As previously described, FIGS. 57D and 57E show the exemplary protrusionof blades 5710 and 5712 as viewed from the top and bottom of a rotorhousing assembly 5420′, respectively. As shown in FIG. 57D versus 57E,the protrusion is more exposed on the top side than the bottom in thisembodiment. In other embodiments, the cutter device has the sameprotrusion for both sides. Biasing the protrusion more on one side thanthe other can provide advantages such as cutting/shreddingdirectionality and/or additional safety. Blade protrusion distances thatapplicants believe are advantageous include less than about 100 microns,less than about 10 microns, substantially flush with the housing,recessed a minimum of about 5 microns, and recessed a minimum of about10 microns.

For tooth pitch, FIG. 58 shows a rotor 5810 with two blade disks 5812and 5814. The pitch P is the distance from one tooth tip 5816 to thenext tooth tip 5816 along an imaginary circle circumscribing the outercircumference of the blade. The trough diameter or depth D generally isthe distance between the tooth tip 5816 and the low point between thetooth tips. In many embodiments, the trough is a critical geometrycomponent that enables tissue selectivity. Additionally, the troughopening O (i.e. the distance from tooth tip 5816 to the tooth back 5818of an adjoining tooth) can determine the size of the “window” forcapturing a fiber or fiber bundle diameter.

As shown in FIG. 58, teeth from one blade 5812 can be designed to be outof phase with teeth from another blade 5814. Designing the blades to beout of phase from one another can be used to reduce the effective troughdiameter by having the teeth of one disk overlap the troughs of anotherdisk. This makes the device more suitable for removing tissue in thinplanes (shaver). A device designed to use this planing mode may rely ona depth stop from the rotor housing to control the thickness of tissueremoved.

Although the mechanical aspects are important attributes of tissueselectivity at this scale, there is another important feature thatenables or further enables selectivity in some embodiments. Aspreviously described, the electronic control system for a closed loopmotor drive can be designed and programmed to enable the sensing of thetorque load (changes in electrical current) and/or changes in velocityat the blade rotors as they are being loaded by the tissue. In someembodiments, this is very important when going from one tissue planeinto another, i.e. muscle to cartilage, cartilage to bone, flavum todura, tumor to nerve, etc. For the cutting of each tissue plane therecan be a known mechanical load that is imparted to the cutter head andsensed by the motor drive electronics and/or microprocessor. When aknown load signature changes (with the exception of a no loadcondition), the system can recognize this change. The surgeon can bealerted to this change, the motor can be stopped under control or themotor speed can be changed to an optimal level for the next tissue typeto be cut.

For a closed loop motor controller, the output current can be limitedand monitored continuously with a high speed microprocessor (torquesensing). Likewise, for velocity monitoring, the servo gains can be setso the motor is under-damped. The change in velocity may be indicated bya tachometer and can be used to indicate a change in load at the cutterhead. Either of these methods of monitoring a change in load (torquesensing, such as by monitoring current) or a change in velocity(velocity sensing, such as with a tachometer) alone or in combinationenable a highly sensitive method of measuring tissue load and detectingtransitions in tissue structures.

In some embodiments, tooth protrusion, tooth pitch, troughdiameter/depth, and trough opening are key geometric blade features thatenable selective tissue removal. The descriptions below that accompanyFIGS. 59-65 illustrate these concepts.

FIG. 59 shows the details of blade protrusion from the edge of ahousing.

FIG. 60 shows how a housing is being used as a depth stop forcontrolling the thickness of tissue being removed from the source. Insome embodiments, the protrusion depth is as small as an individual cellor fiber diameter of 2 microns.

FIG. 61 shows the diameter of the tooth trough matching the diameter ofthe fiber or cell. In some embodiments, the tooth trough diameter is assmall as an individual cell or fiber diameter of 2 microns.

FIG. 62 shows the details of selectivity from small fibers (selected) tolarge fibers (non-selected).

FIGS. 63A-63E show the details of how a tooth tip's angle of attack canbe adjusted to further enhance the selective cutting attributes. Bycreating a negative angle of attack as shown in FIGS. 63C-63E, the toothtip is generally only effective when the fiber diameter is less than orequal to the trough diameter. When the fiber diameter is greater thanthe trough diameter, the fiber is pushed away from the tooth, asdepicted in FIG. 63E. The negative angle of attack can ensure therepulsion of the larger fiber from the tooth's grasp. A positive angleof attack (FIG. 63A) or a neutral angle of attack (FIG. 63B), on theother hand, is less selective than the negative angle of attack (FIG.63C). Adjusting the tip pitch, trough depth, trough opening, protrusiondistance, tooth speed, etc. of tooth tips having positive or neutralangles of attack can enable these tips to also be selective of the typeof tissue they will and will not cut.

FIG. 64 shows different tooth geometries that can be designed into eachrotor. In FIG. 64A, a basic unidirectional grasping tooth is shown. InFIG. 64B, a dual purpose unidirectional tooth 6412 is shown. This designhas a leading grasper type tooth 6414 followed by teeth 6413 that can beused for removing harder materials such as ligament and bone. FIG. 64Cshows a bidirectional tooth 6418 with a grasping cutter 6414 at each endof the tooth. This dual direction cutter can cut in clockwise andcounter-clockwise directions by grasping, pulling and cutting tissuefrom the source, working in the same manner as tooth 6410 depicted inFIG. 64A. FIG. 64D shows a bidirectional cutter 6420 with the samebidirectional cutting attributes as tooth 6418 in FIG. 64C, but withsmaller tooth features 6416 between the two large leading edges, for usein removing harder materials such as ligament and bone.

In FIG. 65, two rotary blades are shown with fibers in tension. In somedouble blade cutter embodiments, the ability to pretension the fiberstightly before cutting is a key attribute. Tensioning fibers beforepulling them between the rotors and shearing them from the sourceenables the device to remove soft tissue in a swath that is as wide asor wider than the width or diameter of the cutter head. This process ofpre-tensioning the tissue fibers before cutting enables soft tissue tobe cut and/or removed in a manner similar to how rigid materials areprecisely cut and shaped using controlled industrial machiningprocesses.

Tooth tip velocity along with tooth geometry is another means ofcontrolling selective tissue removal, according to aspects of thepresent invention. A cutting device can be made non-selective for aparticular tissue by adding a negative angle of attack to the teeth anddriving the rotors at a fast speed, such that the tissue fibers arebumped or pushed away from the tooth troughs. By decreasing the speedalong with the use of suction and/or pressure against the target tissue,the selected fibers matching the trough diameter are pulled inwardbetween the blade rotors. At this point, the device works at an optimalspeed for selective tissue removal without abrasion or tearing to thelarger non-selected tissue fibers.

In some embodiments, the target tissue being cut is hydrated andgenerally has a nominal fiber diameter of about 6 to about 9 microns. Insome embodiments, the target tissue being cut is dry and generally has anominal fiber diameter of about 5 to about 6 microns. In someembodiments, the tissue fibers are connected together in bundles havinga nominal diameter of about 250 microns.

-   -   Typical dimensions in some embodiments include:    -   Housing diameter: 6 mm or less    -   Blade diameter range: 0.75 mm to 4 mm    -   Tip to Tip range: 0.2 mm to 1 mm    -   Trough diameter range: 2 microns to 0.5 mm    -   Blade protrusion range: 2 microns to 2 mm    -   The tip to tip distance is typically at least two times the        trough diameter for hook type teeth.

FIGS. 66A-66M show 13 further examples of cutter heads constructedaccording to aspects of the present invention.

The tissue cutting devices disclosed herein may be configured for use ina variety of procedures. An example of a cardiac application is usingthe inventive devices to selectively remove endocardium, with thecutting device configured to leave the underlying myocardium uncut. Anexample of a tissue removing application involving the esophagusincludes selectively removing mucosa, leaving the submucosa. Such atherapy would be useful for treating Barrett's disease. Examples in thespinal area include selectively removing flavum, with the cutting deviceconfigured to stop removing tissue when dura is reached, leaving thedura intact. Selective removal of flavum but not nerve root is anotherembodiment. A cutting device constructed according to aspects of theinvention can also be configured to remove flavum without cutting bone.In this embodiment, the rotor velocity could be changed and/or thecutting elements could be changed after the flavum is removed such thatsome bone tissue could then be removed. Examples in the neurovasculararea include selectively removing cancerous tissue while not cuttingadjacent blood vessel tissue or nerve tissue. In the rheumatology field,tears in labral target tissue may be selectively removed whilepreserving adjacent non-target tissue, such as in the hips, shoulders,knees, ankles, and small joints. In some embodiments, small teeth on therotors can interact with micron scale fibers of cartilage, removingtissue in a precise way, much like precision machining of materials thatare harder than tissue. Other target tissues that may be selectivelyremoved by the inventive devices and methods described herein includecartilage, which tends to be of a medium density, periosteum, stones,calcium deposits, calcified tissue, cancellous bone, cortical bone,plaque, thrombi, blood clots, and emboli.

It can be appreciated by those skilled in the art of tissue removal thatsoft tissue is much more difficult to remove in a small quantitiesand/or in a precise way than harder tissue such as bone that may begrinded or sculpted, since soft tissue tends to move or compress whenbeing cut, rather than cut cleanly. Cutting tissue rather than removingit with a laser or other high energy device has the advantage of notoverheating the tissue. This allows the tissue to be collected and itspathology tested, as previously described.

In some embodiments of the invention, the selective tissue cutting toolmay be moved laterally along a tissue plane, removing thin swaths oftissue with each pass until the desired amount or type of tissue isremoved. In some embodiments, the tool may be plunged into the targettissue in a distal direction, until a desired depth or type of tissue isreached. In any of these embodiments, the tool may cut a swath or borethat is as large as or larger than the width of the tool head. In someembodiments, the cutting elements are distally facing, laterally facing,or both.

FURTHER COMMENTS AND CONCLUSIONS

Structural or sacrificial dielectric materials may be incorporated intoembodiments of the present disclosure in a variety of different ways.Such materials may form a third material or higher deposited on selectedlayers or may form one of the first two materials deposited on somelayers. Additional teachings concerning the formation of structures ondielectric substrates and/or the formation of structures thatincorporate dielectric materials into the formation process andpossibility into the final structures as formed are set forth in anumber of patent applications filed on Dec. 31, 2003 listed in the tablebelow. These patent filings are each hereby incorporated herein byreference as if set forth in full herein.

Some embodiments may employ diffusion bonding or the like to enhanceadhesion between successive layers of material. Various teachingsconcerning the use of diffusion bonding in electrochemical fabricationprocesses are set forth in the '384 application set forth in the tablebelow. This application is hereby incorporated herein by reference as ifset forth in full.

Some embodiments may incorporate elements taught in conjunction withother medical devices as set forth in various U.S. patent applicationsfiled by the owner of the present application and/or may benefit fromcombined use with these other medical devices: Some of these alternativedevices have been described in some of the patent applications set forthin the table below. Each of these applications is incorporated herein byreference as if set forth in full herein.

Though the embodiments explicitly set forth herein have consideredmulti-material layers to be formed one after another. In someembodiments, it is possible to form structures on a layer-by-layer basisbut to deviate from a strict planar layer on planar layer build upprocess in favor of a process that interlaces material between thelayers. Such alternative build processes are disclosed in the '519application set forth in the table below. The techniques disclosed inthis referenced application may be combined with the techniques andalternatives set forth explicitly herein to derive additionalalternative embodiments. In particular, the structural features arestill defined on a planar-layer-by-planar-layer basis but materialassociated with some layers are formed along with material for otherlayers such that interlacing of deposited material occurs. Suchinterlacing may lead to reduced structural distortion during formationor improved interlayer adhesion. This patent application is hereinincorporated by reference as if set forth in full.

The patent applications and patents set forth below are herebyincorporated by reference herein as if set forth in full. The teachingsin these incorporated applications can be combined with the teachings ofthe instant application in many ways. For example, enhanced methods ofproducing structures may be derived from some combinations of teachings,enhanced structures may be obtainable, enhanced apparatus may bederived, and the like.

US Pat App No., Filing Date US App Pub No., Pub Date US Patent No.,Issue Date Inventor, Title 09/493,496 - Jan. 28, 2000 Cohen, “Method ForElectrochemical Fabrication” — 6,790,377 - Sep. 14, 2004 10/387,958 -Mar. 13, 2003 Cohen, “Electrochemical Fabrication Method and2003-022168A - Dec. 4, 2003 Application for Producing Three-DimensionalStructures — Having Improved Surface Finish” 10/434,294 - May 7, 2003Zhang, “Electrochemical Fabrication Methods With 2004-0065550A - Apr. 8,2004 Enhanced Post Deposition Processing” — 10/434,295 - May 7, 2003Cohen, “Method of and Apparatus for Forming Three- 2004-0004001A - Jan.8, 2004 Dimensional Structures Integral With Semiconductor — BasedCircuitry” 10/434,103 - May 7, 2004 Cohen, “Electrochemically FabricatedHermetically 2004-0020782A - Feb. 5, 2004 Sealed Microstructures andMethods of and Apparatus 7,160,429 - Jan. 9, 2007 for Producing SuchStructures” 10/841,006 - May 7, 2004 Thompson, “ElectrochemicallyFabricated Structures 2005-0067292 - May 31, 2005 Having Dielectric orActive Bases and Methods of and — Apparatus for Producing SuchStructures” 10/434,519 - May 7, 2003 Smalley, “Methods of and Apparatusfor 2004-0007470A - Jan. 15, 2004 Electrochemically FabricatingStructures Via Interlaced 7,252,861 - Aug. 7, 2007 Layers or ViaSelective Etching and Filling of Voids” 10/841,347 - May 7, 2004 Cohen,“Multi-step Release Method for Electrochemically 2005-0072681 - Apr. 7,2005 Fabricated Structures” — 60/534,183 - Dec. 31, 2003 Cohen, “Methodand Apparatus for Maintaining — Parallelism of Layers and/or AchievingDesired — Thicknesses of Layers During the Electrochemical Fabricationof Structures” 11/733,195 - Apr. 9, 2007 Kumar, “Methods of FormingThree-Dimensional 2008-0050524 - Feb. 28, 2008 Structures Having ReducedStress and/or Curvature” — 11/506,586 - Aug. 8, 2006 Cohen, “Mesoscaleand Microscale Device Fabrication 2007-0039828 - Feb. 22, 2007 MethodsUsing Split Structures and Alignment Elements” — 10/949,744 - Sep. 24,2004 Lockard, “Three-Dimensional Structures Having Feature2005-0126916 - Jun. 16, 2005 Sizes Smaller Than a Minimum Feature Sizeand 7,498,714 - Mar. 3, 2009 Methods for Fabricating” 14/181,247 - Feb,14, 2014 Chen, “Concentric Cutting Devices for Use in Minimally2014-0163596 - Jun. 12, 2014 Invasive Medical Procedures” 14/033,397 -Sep. 20, 2013 Schmitz, “Micro-Mechanical Devices and Methods for2014-0148729 - May 29, 2014 Brain Tumor Removal” — 14/440,088 - May 1,2015 Schmitz, “Micro-Mechanical Device and Method for 2015-0265336 -Sep. 24, 2015 Obstructive Sleep Apnea Treatment” 15/167,899 - May 27,2016 Schmitz, “Solderless Microcircuit Boards, Components, — Methods ofMaking, and Methods of Using” — 15/292,029 - Oct. 12, 2016 Schmitz,Surgical Micro-Shears and Methods of 2017-0095264 - Spr. 6, 2017Fabrication and Use —

Though various portions of this specification have been provided withheaders, it is not intended that the headers be used to limit theapplication of teachings found in one portion of the specification fromapplying to other portions of the specification. For example, it shouldbe understood that alternatives acknowledged in association with oneembodiment, are intended to apply to all embodiments to the extent thatthe features of the different embodiments make such applicationfunctional and do not otherwise contradict or remove all benefits of theadopted embodiment. Various other embodiments of the present inventionexist. Some of these embodiments may be based on a combination of theteachings herein with various teachings incorporated herein byreference.

It is intended that the aspects of the invention set forth hereinrepresent independent invention descriptions which Applicantcontemplates as full and complete invention descriptions that Applicantbelieves may be set forth as independent claims without need ofimporting additional limitations or elements, from other embodiments oraspects set forth herein, for interpretation or clarification other thanwhen explicitly set forth in such independent claims once written. It isalso understood that any variations of the aspects set forth hereinrepresent individual and separate features that may form separateindependent claims, be individually added to independent claims, oradded as dependent claims to further define an invention being claimedby those respective dependent claims should they be written.

In view of the teachings herein, many further embodiments, alternativesin design and uses of the embodiments of the instant invention will beapparent to those of skill in the art. As such, it is not intended thatthe invention be limited to the particular illustrative embodiments,alternatives, and uses described above but instead that it be solelylimited by the claims presented hereafter.

We claim:
 1. A method of removing tissue from a target location in a subject, comprising: positioning a distal housing of a medical device to a target tissue site, wherein the distal housing comprises a first rotatable member and a second rotatable member; rotating the first and second rotatable members in opposite directions; directing tissue at the tissue site into the distal housing between the oppositely rotating first and second rotatable members.
 2. The method of claim 1 further comprising advancing the first rotatable member and the second rotatable member into tissue to cause the first and second rotating members to direct tissue at the tissue site into the distal housing via a movement selected from the group consisting of: (1) distally oriented movement of the housing, and (2) laterally oriented movement of the housing.
 3. The method of claim 1 wherein the rotating of the first and second rotatable members comprises a function selected from the group consisting of (1) rotating the first rotatable member in a direction opposite that of the second rotatable member; (2) rotating each of the plurality of rotatable members around an axis which is fixed in position relative to the distal housing; and (3) the first and second rotatable member rotate about spaced apart parallel axes of rotation that are substantially orthogonal to a longitudinal axis of the distal housing.
 4. The method of claim 1 wherein the medical device comprises a configuration selected from the group consisting of: (1) each of the plurality of rotatable members are configured to rotate around an axis which is fixed in position relative to the distal housing and wherein each of the plurality of rotatable members includes a plurality of teeth adapted to direct the tissue into the distal housing; (2) each of the first and second rotatable members comprise a plurality of rotatable elements in a stacked formation and the rotatable members of the first and second rotatable members are interdigitated with the elements of the other of the first and second rotatable members; (3) a drive mechanism to drive the rotation of the first and second rotatable members; (4) a drive mechanism coupler, the supported by the distal housing, which receives a distal portion of the drive mechanism such that the drive mechanism can drive the rotation of the drive mechanism coupler; (5) a drive mechanism coupler, supported by the distal housing, adapted to drive at least one gear train in the distal housing, where the at least one gear train is coupled to at least one of the rotatable members; (6) a drive mechanism at least partly disposed within the elongate member and in the distal housing; (7) a drive mechanism extends proximally from the distal housing through the elongate member, and wherein the proximal end of the drive mechanism is controlled by an actuator in an external actuation device; (8) the distal housing includes a first gear train which drives a first rotatable member, and a second gear train which drives a second rotatable member, wherein the first and second gear trains rotate the first and second rotatable members in opposite directions; (9) the first and second rotatable members extend from a distal end of the distal housing; (10) the distal housing comprises a first gear train to drive a first rotatable member, wherein a first gear in the gear train comprises a first tooth and a second tooth, wherein the first tooth and second tooth each lie in a plane orthogonal to the axis of rotation of the gear, and wherein the first and second planes are not the same and where the first and second planes do not overlap along a height dimension of the gear; and (11) an elongate introducer coupled to the distal housing for advancing the distal housing adjacent target tissue.
 5. A method of selectively removing target tissue from a body, the method comprising: providing a tissue cutting instrument capable of distinguishing between target tissue to be removed and non-target tissue; urging the instrument against the target tissue and the non-target tissue; and allowing the instrument to cut the target tissue while automatically avoiding cutting of non-target tissue.
 6. The method of claim 5, further comprising automatically discontinuing tissue cutting once the instrument is contacting only non-target tissue.
 7. The method of claim 5, further comprising allowing the instrument to remove the target tissue from the body as it is being cut.
 8. The method of claim 5 wherein the tissue cutting instrument is configured according to the group consisting of: (1) configured to distinguish between the target tissue and the non-target tissue by sensing an electrical current level being delivered to a cutter motor; (2) configured to distinguish between the target tissue and the non-target tissue by electronically sensing a cutter drive velocity; (3) configured to sense at least one parameter selected from the group consisting of: capacitance, inductance, optical changes, pressure, proximity and position; (4) configured to allow cutting of the target tissue while automatically avoiding cutting of non-target tissue by permitting modulation of a cutter speed; and (5) configured to allow cutting of the target tissue while automatically avoiding cutting of non-target tissue by permitting modulation of suction in a port adjacent to a cutter head of the instrument.
 9. The method of claim 5, wherein the tissue cutting instrument comprises cutter elements that are tuned to capture elements of the target tissue and reject elements of the non-target tissue.
 10. The method of claim 9, wherein the cutter elements additionally comprise an element selected from the group consisting of: (1) at least one cutting tooth and at least one trough adjacent the tooth, the at least one trough having a nominal diameter that is matched to a diameter of a fiber or fiber bundle of the target tissue and (2) a plurality of cutting teeth having a pitch that is matched to a diameter of a fiber or fiber bundle of the target tissue.
 11. The method of claim 5, wherein the tissue cutting instrument comprises a rotating cutting element covered by a cutter housing, the cutter housing having a tissue access opening adjacent to a portion of the cutting element through which tissue must extend to contact the cutting element, the arrangement being configured to allow cutting of the target tissue while automatically avoiding cutting of non-target tissue, wherein a maximum outside diameter of the cutting element is recessed from the tissue access opening and has a maximum outer diameter selected from the group consisting of: (1) less than about 5 microns, (2) less than about 10 microns, (3) less than about 20 microns, (4) less than about 50 microns, and (5) less than about 100 microns.
 12. The method of claim 5, wherein the instrument is configured according to the group consisting of: (1) to remove a maximum of about 2 microns of target tissue at a time; (2) to remove a maximum of about 5 microns of target tissue at a time; (3) to remove a maximum of about 10 microns of target tissue at a time; and (4) to remove a maximum of about 100 microns of target tissue at a time.
 13. The method of claim 5, wherein the target tissue comprises a material selected from the group consisting of: (1) endocardium and the non-target tissue comprises myocardium; (2) mucosa and the non-target tissue comprises submucosa wherein the mucosa and the submucosa are located in an esophagus; (3) flavum and the non-target tissue comprises dura mater; (4) flavum and the non-target tissue comprises nerve roots; (5) flavum and the non-target tissue comprises bone; (6) prostate tissue and the non-target tissue comprises nerve tissue; (7) soft tissue and the non-target tissue comprises tendon; (8) soft tissue and the non-target tissue comprises cartilage; (9) cartilage and the non-target tissue comprises bone; (10) cancerous tissue and wherein the non-target tissue comprises vascular tissue; (11) cancerous tissue and wherein the non-target tissue comprises nerve tissue; (12) labrum; (13) plaque and the non-target tissue comprises a vascular wall; (14) calcified tissue and the non-target tissue comprises a vascular wall; (15) a thrombus and the non-target tissue comprises a vascular wall; (16) a blood clot and the non-target tissue comprises a vascular wall; and (17) an embolus and the non-target tissue comprises a vascular wall.
 14. A medical device for removing tissue from a subject, comprising: a distal housing configured with at least one tissue engaging opening; an elongate member coupled to the distal housing and configured to introduce the distal housing to a target tissue site of the subject; a first rotatable member located at least partially within the distal housing and configured to rotate about a first axis, the first rotatable member comprising a first disc-shaped blade having a series of teeth along an outer circumference of the blade, the first blade lying in a first plane; the first rotatable member further comprising a circular first axle portion lying in a second plane that is offset from, parallel and adjacent to the first plane, the first axle portion having an outer circumference that is smaller than that of the first blade, and a second rotatable member located at least partially within the distal housing and configured to rotate about a second axis parallel to and radially offset from the first axis, the second rotatable member configured to rotate in a direction opposite of a direction of rotation of the first rotatable member, the second rotatable member comprising a second disc-shaped blade having a series of teeth along an outer circumference of the blade, the second blade lying in the second plane, the second rotatable member further comprising a circular second axle portion lying in the first plane, the second axle portion having an outer circumference that is smaller than that of the second blade, wherein the first and second blades are directly adjacent to one another and positioned to partially overlap such that tissue may be sheared between the first and second blades, between the first blade and the second axle portion and between the second blade and the first axle portion, the rotatable members configured to engage tissue from the target tissue site with the teeth of the first and second blades, rotate towards one another and inwardly to direct tissue from the target tissue site through the tissue engaging opening and into an interior portion of the distal housing.
 15. The medical device of claim 14, wherein a configuration of the device is selected from the group of configurations consisting of: (1) the first rotatable member further comprises a third disc-shaped blade having a series of teeth along an outer circumference of the blade, the third blade lying in a third plane that is offset from, parallel and adjacent to the second plane, the second rotatable member further comprising a circular third axle portion lying in the third plane, the third axle portion having an outer circumference that is smaller than that of the third blade, wherein the second and third blades are directly adjacent to one another and positioned to partially overlap such that tissue may be sheared between the second and third blades and between the third blade and the third axle portion, the rotatable members configured to engage tissue from the target tissue site with the teeth of the first, second and third blades, rotate towards one another and inwardly to direct tissue from the target tissue site through the tissue engaging opening and into an interior portion of the distal housing; (2) the distal housing further comprises a tissue cutting portion lying in a third plane that is offset from, parallel and adjacent to the second plane, wherein the tissue cutting portion and the second blade are directly adjacent to one another and positioned to partially overlap such that tissue may be sheared between the tissue cutting portion of the distal housing and the second blade; (3) the first and second blades are no more than 30 microns apart where they partially overlap; (4) the outer circumference of the first blade is no more than 30 microns apart from the outer circumference of the second axle portion, and the outer circumference of the second blade is no more than 30 microns apart from the outer circumference of the first axle portion; (5) the first and the second blades and the first and the second axle portions each have a thickness of less than 1 mm; (6) the first and the second rotation axes are generally perpendicular to a longitudinal axis of the elongate member; (7) the rotations of the first and the second rotatable members are synchronized such that a first trough associated with one of the teeth located along the outer circumference of the first blade and a second trough associated with one of the teeth located along the outer circumference of the second blade simultaneously engage a single fiber or single bundle of fibers from the target tissue site; (8) the first and the second troughs cooperate to compress portions of the single fiber or single bundle of fibers as the first and the second rotatable members rotate toward one another, thereby reducing the volume of the tissue entering the distal housing; (9) the rotations of the first and the second rotatable members are configured to alternately rotate in and out of phase with one another; (10) the first and the second rotatable members are independently driven; (11) the first and the second rotatable members are configured to periodically reverse direction of rotation during tissue cutting; (12) the rotations of the first and the second rotatable members are configured to reverse direction at least once per second; and (13) the device is configured to provide a dwell time of at least about 50 milliseconds when the first and the second rotatable members reverse direction.
 16. A method of fabricating the device of claim 14, comprising fabricating the first blade and the second axle portion together in a first material deposition process step and fabricating the second blade and the first axle portion together in a second material deposition process step.
 17. A method of using the device of claim 14, comprising urging the distal housing of the device against a target tissue site of a subject and extracting cut tissue pieces from a proximal end of the elongate member.
 18. A medical device for removing tissue from a subject, comprising: distal housing configured with at least one tissue engaging opening; an elongate member coupled to the distal housing and configured to introduce the distal housing to a target tissue site of the subject, the elongate member having a central longitudinal axis; a first rotatable member located at least partially within the distal housing and configured to rotate about a singular first axis, the first rotatable member comprising a first cutting blade, the first blade having a first side and a second side opposite the first side; a first tissue shearing surface located and configured to cooperate with the first side of the first blade to shear tissue therebetween; and a second tissue shearing surface located and configured to cooperate with the second side of the first blade to shear tissue therebetween, the first rotatable member configured to engage tissue from the target tissue site, rotate towards the first and second tissue shearing surfaces and inwardly to direct tissue from the target tissue site through the tissue engaging opening and into an interior portion of the distal housing.
 19. The medical device of claim 18, wherein a configuration of the device is selected from the group of configurations consisting of: (1) the first cutting blade comprises a disc-shaped portion having a series of teeth along an outer circumference of the blade; (2) the disc-shaped portion is perpendicular to the singular first axis; (3) at least one of the first and second tissue shearing surfaces is formed by a fixed portion of the distal housing; (4) wherein the first axis of the first rotatable member is coincident with the longitudinal axis of the elongate member; (5) the first axis of the first rotatable member intersects the longitudinal axis of the elongate member and is perpendicular therewith; (6) the first axis of the first rotatable member intersects the longitudinal axis of the elongate member and forms an angle therewith of between 0 and 90 degrees; (7) the first axis of the first rotatable member is offset from and parallel to the longitudinal axis of the elongate member and lies in a common plane therewith; (8) the first axis of the first rotatable member is offset from and perpendicular to the longitudinal axis of the elongate member and lies in a common plane therewith; (9) the first axis of the first rotatable member is offset from the longitudinal axis of the elongate member, lies in a common plane and forms an angle therewith of between 0 and 90 degrees; (10) the first axis of the first rotatable member is offset from and perpendicular to the longitudinal axis of the elongate member and lies in a different plane; and wherein at least one of the first and second tissue shearing surfaces is formed by a second rotatable member located at least partially within the distal housing and configured to rotate about a singular second axis parallel to and offset from the first axis, the second rotatable member is configured to rotate in a direction opposite of a direction of rotation of the first rotatable member, the second rotatable member comprising a second disc-shaped blade having a series of teeth along an outer circumference of the blade; and wherein the second rotatable member comprises a third disc-shaped blade having a series of teeth along an outer circumference of the blade, wherein the three blades are positioned such that they are interdigitated with one another; (11) the first axis of the first rotatable member is offset from the longitudinal axis of the elongate member, lies in a different plane and forms an angle therewith of between 0 and 90 degrees; wherein at least one of the first and second tissue shearing surfaces is formed by a second rotatable member located at least partially within the distal housing and configured to rotate about a singular second axis parallel to and offset from the first axis, the second rotatable member configured to rotate in a direction opposite of a direction of rotation of the first rotatable member, the second rotatable member comprising a second disc-shaped blade having a series of teeth along an outer circumference of the blade; and wherein the second rotatable member comprises a third disc-shaped blade having a series of teeth along an outer circumference of the blade, wherein the three blades are positioned such that they are interdigitated with one another; (12) the first axis of the first rotatable member is perpendicular to the longitudinal axis of the elongate member and is configured to articulate with respect thereto and wherein the first axis pivots about an articulation axis that is parallel thereto; (13) the first axis of the first rotatable member is perpendicular to the longitudinal axis of the elongate member and is configured to articulate with respect thereto and wherein the first axis pivots about an articulation axis that is perpendicular thereto; (14) the elongate member comprises a distal portion that is oriented at an angle with respect to a more proximal portion of the elongate member such that the central longitudinal axis has an inflection point between the distal portion and more proximal portion; and wherein a distal portion of the central longitudinal axis and a more proximal portion of the central longitudinal axis lie in a common plane that is coincident with or generally parallel to the first axis of the first rotatable member; (15) the elongate member comprises a distal portion that is oriented at an angle with respect to a more proximal portion of the elongate member such that the central longitudinal axis has an inflection point between the distal portion and more proximal portion; and wherein a distal portion of the central longitudinal axis and a more proximal portion of the central longitudinal axis lie in a common plane that is generally perpendicular to the first axis of the first rotatable member; (16) the elongate member comprises a generally rigid, curved distal portion and a generally straight more proximal portion; and wherein a curved, distal portion of the central longitudinal axis lies in a plane that is coincident with or generally parallel to the first axis of the first rotatable member; and (17) the elongate member comprises a generally rigid, curved distal portion and a generally straight more proximal portion; and wherein a curved distal portion of the central longitudinal axis lies in a plane that is generally perpendicular to the first axis of the first rotatable member.
 20. A medical device for removing tissue from a subject, comprising: a distal housing configured with a tissue cutter assembly; an elongate member coupled to the distal housing and configured to introduce the distal housing to a target tissue site of the subject, the elongate member having an outer tube, an inner drive tube rotatably mounted within the outer tube, the inner drive tube having a crown gear located on a distal end thereof and comprising a plurality of gear teeth, wherein the crown gear teeth have opposing side surfaces that taper towards a center point of the inner drive tube, the inner drive tube having an outer diameter no greater than 12 mm and no smaller than 0.5 mm; a first rotatable member and a second rotatable member each rotatably mounted to the tissue cutter assembly, the first and the second rotatable members each comprising a plurality of disc shaped blades, wherein each of the plurality of blades of the first rotatable member lies in a plane parallel to and axially offset from a plane of another of the blades of the first rotatable member, each of the plurality of blades of the first and the second rotatable members being directly adjacent to at least one parallel surface and positioned to partially overlap the adjacent parallel surface such that tissue may be sheared between the adjacent, overlapping blades and parallel surfaces and such that the first and the second rotatable members are configured to rotate in opposite directions to direct tissue into an interior portion of the distal housing; a first drive gear train coupled between the crown gear and the first rotatable member, the first drive gear train comprising a first spur gear having a plurality of gear teeth arranged to mesh with the gear teeth of the crown gear and a second spur gear having a plurality of gear teeth arranged to mesh with the gear teeth of the first spur gear, the first and the second spur gears being configured to rotate about axes that are perpendicular to an axis of rotation of the crown gear, wherein the crown gear teeth and the second spur gear teeth have a convex profile and the first spur gear teeth have a concave profile, wherein the crown gear teeth and the second spur gear teeth have a mid-point base thickness that is greater than a base thickness of the first spur gear teeth; and a second drive gear train coupled between the crown gear and the second rotatable member, the second drive gear train comprising a third spur gear having a plurality of gear teeth arranged to mesh with the gear teeth of the crown gear and a fourth spur gear having a plurality of gear teeth arranged to mesh with the gear teeth of the third spur gear, the third and the fourth spur gears being configured to rotate about axes that are perpendicular to the axis of rotation of the crown gear, wherein the fourth spur gear teeth have a convex profile and the third spur gear teeth have a concave profile, wherein the crown gear teeth and the fourth spur gear teeth have a mid-point base thickness that is greater than a base thickness of the third spur gear teeth.
 21. The medical device of claim 19, wherein a tangent to a mid-point base thickness of the teeth of the second spur gear slopes away from a tip of the teeth of the second spur gear to create a bulging tip section of the teeth of the second spur gear to reduce backlash between the teeth of second spur gear and the teeth of the first spur gear, and wherein a tangent to a mid-point base thickness of the teeth of the fourth spur gear slopes away from a tip of the teeth of the fourth spur gear to create a bulging tip section of the teeth of the fourth spur gear to reduce backlash between the teeth of fourth spur gear and the teeth of the third spur gear. 